Alphatec Spine, Inc. – FDA Warning Letter
This Warning Letter, dated January 11, 2011, was issued to Alphatec Spine, Inc. for failing to comply with postmarket surveillance requirements for their Zodiac DynaMo Semi-Rigid Spinal System (K072081), ISOBAR Semi-Rigid Spinal System (K991326), and ISOBAR Semi-Rigid Dual Dampener (K071261).
FDA ordered postmarket surveillance on October 5, 2009, under section 522 of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 822. On July 30, 2010, FDA notified Alphatec that their submitted study protocol lacked necessary information and required a complete response within 30 days. A follow-up letter on September 10, 2010, noted the overdue protocol and demanded submission within 14 days.
Alphatec Spine, Inc. failed to revise and submit their postmarket surveillance submission addressing the deficiencies identified in the July 30, 2010, approvable letter within the specified timeframe, violating 21 CFR 822.19(b). This failure renders their devices misbranded under section 502(t)(3) of the Act.
The FDA requires prompt corrective action. Failure to comply may result
- Company
- Alphatec Spine, Inc.
- Product type
- Devices
ID · 618f77f0-1ff9-43e8-92dd-2bec20b710f0
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