Vertical Expandable Prosthetic Titanium Rib
by Depuy Synthes Spine, Inc. 510(k)
Active
510(k) K142587
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142587 | Date18 Nov 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-2488-2015
The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
Specification
- 510(k) Number
- FDA Product Code
- MDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent