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G Surgical Announces FDA Clearance of their PEEK Cervical Spacer

May 31, 2015 By SPINEMarketGroup

Boulder, CO (May 26, 2015) –G Surgical, a privately held medical device company offering innovative spinal implants, announced that it has received 510(k) clearance from the United States
Food and Drug Administration to market their PEEK Cervical Spacer. The PEEK Cervical Spacer adds to the company’s portfolio and compliments the T-Lok Anterior Cervical System which has been used in more than 5,000 implantations worldwide.

The G Surgical PEEK Cervical Spacer is designed to provide initial and long-term stability. The cervical interbody fusion device is made from radiolucent polymer. The G Surgical spacer is available in numerous footprints, heights and sagittal profiles to accommodate various patient anatomies. Included in the system are innovative instruments designed to streamline the anterior cervical fusion procedure.

The G Surgical PEEK Cervical Spacer compliments the T-Lok Anterior Cervical System. The T-Lok system is an innovative anterior plating system that has been used in over 5000 surgeries. The T-Lok system features a low profile, 1.9mm, plate and a one-step locking mechanism. A single instrument to insert and lock the screws in place.

Don Grafton, President and CEO of G Surgical, comments, “We are excited to strengthen our portfolio by introducing the PEEK Cervical Cage into the U.S. market. G Surgical has led the way in providing surgeons with the highest quality surgical solutions while maintaining cost effectiveness for cervical and lumbar fusions.”

G Surgical was founded in G Surgical was founded in 2009 by Don Grafton. G Surgical provides world class spinal products with headquarters in the United States and with offices in Thailand and Malaysia. G Surgical’s culture and experienced team allows us to respond swiftly to customer needs and places G Surgical in the forefront to strategically compete in a changing market environment. More information is located at www.gsurgical.com.

For Additional Information:

Company Contact: James Thomas, Director of Sales and Marketing for G Surgical (512) 968-5000 [email protected]

(Visited 9 times, 3 visits today)

Filed Under: 2013-2019, 2015, FDA

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