Avs Tl Peek Spacers
510(k) K083661
Avs Tl Peek Spacers is a Class II device made by Stryker Corp., cleared under FDA 510(k) K083661 on 27 Feb 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083661 | Date27 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K083661
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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