Loda Wrist Prosthesis
by Depuy, Inc. 510(k)
Active
510(k) K790774
Overview
The Loda Wrist Prosthesis is a semi-constrained wrist prosthesis. This device is designed to function as a wrist joint replacement.
This device is classified as a Class II medical device under regulation number 888.3800. It received FDA 510(k) clearance under K790774.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790774 | Date3 Aug 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWM
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3800
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent