Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
510(k) K173499
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173499 | Date19 Mar 2018 | StatusActive |
Recalls
-
- Ongoing Z-0313-2022
XXX
-
- Ongoing Z-0314-2022
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDG
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent