510(k) K112905 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
| Applicant | Biomet Orthopedics, LLC, Warsaw IN, US |
| Decision | Substantially Equivalent, May 24, 2012 |
| Received | Oct 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. Compress, Mini Compress; Item Nos. 178350
178351
178352
178353
178354
178355
178356
178357
178358
178359
178360
178361
178362
178363
178364
178365
178366
178367
178368
178369
178370
178371
178372
1783 Terminated |
KWY | None listed |
| Oct 12, 2018 | Zimmer Biomet, Inc. Zimmer Compress Devices and Instruments:
Item Number/Item Description
178350 Compress Device Anti-Rotation Spindle
178353 Compress Device Anti-Rotation Spindle
178356 Compress Device Anti-Rotation Spi Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.