Wmt Composite Dbm
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K083270
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083270 | Date27 Aug 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0564-2020
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Specification
- 510(k) Number
- FDA Product Code
- MQV
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent