510(k) K992367 ยท HWC Screw, Fixation, Bone
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
| Applicant | Electro-Biology, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Sep 23, 1999 |
| Received | Jul 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit)
Item Nos: HAA60-09030
HAA60-09040
HAA60-10030
HAA60-10040
HAA60-11030
HAA60-11040
HAA60-11050
HAA60-12040
HAA60-12060 Terminated |
KTT | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Screw, fixation, bone. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.