510(k) K180433 · NKB Thoracolumbosacral Pedicle Screw System
ENNOVATE®
| Applicant | Aesculap Implant Systems, LLC, Center Valley PA, US |
| Decision | Substantially Equivalent, Apr 26, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2022 | Aesculap Implant Systems LLC Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.
Article Number: 52758014 Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.