FDA

TAICHUNG, Taiwan, Dec. 19, 2022 /PRNewswire/ — SURGLASSES announced today that Caduceus S AR Spine Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration and is ready to launch its products into the US market in the first quarter of 2023. Caduceus S is an augmented reality spine navigation system that will require only few-shots […]

SAN CARLOS, Calif., Dec. 19, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included Module III, with data and analysis of the two-year […]

PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/ — Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® Facet Fixation System (FFS) for a new indication. The Facet Fixation System (FFS) is a novel integrated cage and screw […]

Huntley, IL, December 14th, 2022–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Utilizing expandable technology and […]

Plano, TX, November 08, 2022 –(PR.com)– Eminent Spine received 510(K) approval of their ALIF Stand-Alone System as of October 17, 2022. Eminent Spine will showcase the ALIF Stand-Alone System at the 50th CSRS conference in San Diego, CA on November 16 – 19, 2022. The ALIF implant was designed with the following: a tapered nose which […]

PALM BEACH GARDENS, Fla., Nov. 03, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced that the U.S. Food & Drug Administration (FDA) had cleared Accelus’s 510(k) application for its Remi™ Robotic Navigation System […]

ST. LOUIS, Oct. 13, 2022 /PRNewswire/ — ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous titanium cervical interbody device. “Surgeons have many options for cervical interbodies. The Flux-C porous titanium device […]

DALLAS (PRWEB) OCTOBER 11, 2022–CTL Amedica Corporation has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market its MONDRIAN™ Anterior Lumbar Interbody Fusion (ALIF) Cage System with Supplementary Fixation Plate. The MONDRIAN™ ALIF Cage System with Supplementary Fixation Plate, designated K213641/S003, is an integrated plate-and-cage construct, that can be manufactured in […]

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the GHOST 3D-Printed Titanium Spacer Systems. GHOST 3D-Printed Titanium Spacer System expands on Life Spine’s […]

CARLSBAD, Calif., Oct. 04, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the patented minimally invasive SiLO […]

DEERFIELD, Ill., Aug. 24, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, today announced FDA 510(k) clearance of the CorteraTM Spinal Fixation System. This new flagship product from Surgalign is a key piece to the foundational […]

FLOWOOD, Miss., Aug. 18, 2022 /PRNewswire/ — Zavation Medical Products (“Zavation” or the “Company”), an innovative designer and manufacturer of high-quality spinal implants, instruments, MIS procedural kits, and biologics headquartered in Flowood, MS, announced the FDA 510K Clearance of Varisync™, a cervical intervertebral body fusion device. Varisync™, the most recent addition to the Zavation cervical spine portfolio, has been tested and […]

MINERAL SPRINGS, N.C. (PRWEB) JULY 14, 2022 Cutting Edge Spine (CES), a leader in the organic development and commercialization of bioactive implant technologies for the spine, today announced the FDA 510(k) clearance of its proprietary SI Joint Fusion System, T-FIX 3DSI Joint Fusion System. The 3D-printed T-FIX 3DSI Joint Fusion System is part of the novel EVOL-SI Fusion […]

SANTA CLARA, Calif., June 13, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today announced an FDA clearance for iFuse-TORQ® for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures.* Fractures covered in this clearance include pelvic fragility fractures (fractures related […]

FLOWOOD, Miss., June 10, 2022 /PRNewswire/ — Zavation Medical Products (“Zavation” or the “Company”), an innovative designer and manufacturer of high-quality spinal implants, instruments, MIS procedural kits, and biologics headquartered in Flowood, MS, announced the FDA 510K Clearance of eZspand™ Lateral, an expandable lumbar interbody fusion device. The eZspand™ Lateral, part of the Zavation eZspand™ Interbody System, features unmatched expandable […]

CARLSBAD, Calif, June 06, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that it had received FDA 510(k) clearance for its DEXA SOLO-L™ spinal fusion system. The 3D printed standalone anterior lumbar interbody […]

LYON, France–(BUSINESS WIRE)–Regulatory News: SMAIO (Software, Machines and Adaptative Implants in Orthopaedics – Euronext Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA, eligible for PEA-PME equity savings plans), a French player specialized in complex spine surgery with a global offer comprising software, adaptative implants and related services, today announced that it has received FDA 510(k) clearance for its Balance Analyzer 3D […]

Stryker Corp. announced today that the Q Guidance System has received 510(k) clearance from the U.S. Food and Drug Administration. The company said its Q Guidance System, when used with the Spine Guidance Software, is an advanced planning and intraoperative guidance system designed to enable open or percutaneous computer-assisted surgery. Stryker said the Spine Guidance […]

SANTA CLARA, Calif., May 31, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite Implant System (Granite). The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental […]

PALM BEACH GARDENS, Fla., May 19, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Toro Lateral (Toro-L) […]

DALLAS (PRWEB) MAY 18, 2022–CTL Amedica Corporation has received official 510k clearance from the U.S. Food and Drug Administration (FDA) to market the CTL Amedica Navigation Instrument System, registration number K213491. The system features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in precisely locating anatomical structures in […]

PALM BEACH GARDENS, Fla., May 12, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its FlareHawk TiHawk™11 Interbody […]

Clariance Spine is proud to announce that Aggeris-C received 510(k) clearance. Aggeris-C is low profile anterior cervical plate system designed with the following features in mind: PRE-LORDOSED PLATEPre-lordosed plate conforms to the patient’s cervical vertebrae for enhanced stability. LOW PROFILELow profile to reduce the risk of contact with and irritation to soft tissues. SECURED PLATEVariable angle […]

DALLAS, TX, May 9, 2022 – Osseus, an innovative spinal solutions company, announces FDA 510(k) clearance and launch of the Pisces™-SA Standalone ALIF Interbody System. The Pisces™-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility. Biomechanical testing proved that the Pisces™-SA anchors provide better expulsion resistance than the competition and perform comparably with traditional screw-based standalone ALIF constructs in stabilizing injured spinal segments. The Pisces™-SA is the first of its […]

IRVING, TX – April 4, 2022 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its El Capitan Oblique Anterior Lumbar Interbody Fusion (ALIF) System. Built from the foundation of success with the company’s other integrated plate and […]

PARIS and BOULDER (CO), April 4, 2022, at 06:00pm CEST – SpineGuard (FR0011464452 – ALSGD)  (Paris:ALSGD), an innovative company that deploys its DSG (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, announced today the authorization under 510K #220160 by the FDA (Food and Drug Administration) to commercialize in the United […]

Huntley, IL, March 29th, 2022 –Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that is has received clearance from the U.S. Food & Drug Administration (FDA) to market SImpact Si Joint Fixation System for Posterior-Oblique approaches. Whether the physician is performing […]