Hip Fixation System
by Medtec LLC
510(k) K950866
Hip Fixation System is a Class II device made by Medtec LLC, cleared under FDA 510(k) K950866 on 30 May 1995, 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 | NumberK950866 | Date30 May 1995 | StatusActive |
Official records
- FDA 510(k) database K950866
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Medtec, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K950866
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Groin Piece MTPLVCSUB8 | MTPLVCSUB8 / MTPLVCSUB8 | 00841439107072 | Width 1 in; Length 4 in | On the market |
| HipFix® Baseplate MTPLVC04 | MTPLVC04 / MTPLVC04 | 00841439107058 | — | No longer on the market |
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