510(k) K142576 ยท NKB Thoracolumbosacral Pedicle Screw System
Spinal System
| Applicant | Eisertech, LLC, Poway CA, US |
| Decision | Substantially Equivalent, Feb 26, 2015 |
| Received | Sep 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2015 | Exactech, Inc. Exactech Ambassador Cervical Plate System
The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.