510(k) K101070 ยท NKB Thoracolumbosacral Pedicle Screw System
EXPEDIUM SPINE SYSTEM
| Applicant | Medos International SARL, Raynham MA, US |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | Apr 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2015 | DePuy Spine, Inc. EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.