510(k) K100623 ยท NKB Thoracolumbosacral Pedicle Screw System
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
| Applicant | Aesculap Implant Systems, Center Valley PA, US |
| Decision | Substantially Equivalent, Jun 9, 2010 |
| Received | Mar 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2012 | Aesculap Implant Systems LLC Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T).
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and no Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.