510(k) K082078 ยท HRS Plate, Fixation, Bone
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 3, 2008 |
| Received | Jul 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticular locking plate elbow-sterile, Item Nos.
47235800503
47235800509
47235800511
47235800515
47235800519
47235800603
47235800605
47235800607
47235800609
47235800611
47235800615
47235800619
472 Terminated |
HRS | None listed |
| Dec 27, 2013 | Zimmer, Inc. FEM COND BUTTRESS PLT, RT. Terminated |
HRS | None listed |
| Dec 27, 2013 | Zimmer, Inc. DIST LAT FEM LOCK PLT, LT Terminated |
FZS | None listed |
| Dec 27, 2013 | Zimmer, Inc. DIST LAT FEM LOCK PLT, RT Terminated |
HRS | None listed |
| Dec 27, 2013 | Zimmer, Inc. ITST THREADED GUIDE PIN Terminated |
FZX | None listed |
| Dec 27, 2013 | Zimmer, Inc. FEM COND BUTTRESS PLT, LT Terminated |
HRS | None listed |
| Aug 27, 2013 | Zimmer, Inc. ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT
RIGHT 11 HOLES 178 MM LENGTH
STERILE RX ONLY
Product Usage: Usage:
The Periarticular Locking Plate System Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.