Variax Elbow System
by Howmedica Osteonics Corp. 2 variants
510(k) K101056
Variax Elbow System is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K101056 on 13 May 2010, 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 | NumberK101056 | Date13 May 2010 | StatusActive |
Official records
- FDA 510(k) database K101056
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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