Vented Cement Restrictor
510(k) K022729
Vented Cement Restrictor is a Class II device made by Amedica Corp., cleared under FDA 510(k) K022729 on 14 Nov 2002, 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 | NumberK022729 | Date14 Nov 2002 | StatusActive |
Official records
- FDA 510(k) database K022729
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.4580
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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