510(k) K150121 ยท HRS Plate, Fixation, Bone
Zimmer Periarticular Plating System
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 23, 2015 |
| Received | Jan 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. ZPLP Fibular Plate, Item Nos. 00234701504
00234701506
00234701508
00234701510
00234701512
00234701516
00234701604
00234701606
00234701608
00234701610
00234701612
00234701614
00234701616
00234701702
00 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticular Plates - Tibial, Item Nos. 00234700304
00234700306
00234700308
00234700310
00234700312
00234700314
00234700316
00234700404
00234700406
00234700408
00234700410
00234700412
00234700414
002 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106
00234700108
00234700110
00234700112
00234700114
00234700116
00234700118
00234700206
00234700208
00234700210
00234700212
00234700214
00234700216
0023 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104
00234800106
00234800108
00234800110
00234800112
00234800114
00234800116
00234800204
00234800206
00234800208
00234800210
0023 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504
00234800506
00234800508
00234800510
00234800512
00234800514
00234800604
00234800606
00234800608
00234800610
00234800612
00 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos.
00234801303
00234801304
00234801306
00234801308
00234801310
00234801312
00234801403
00234801404
00234801406
00234801408
00234801410
00234801412 Terminated |
HRS | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 24 consists of all product under product code: HRS and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
HRS | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 27 consists of all product under product code: HSB and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
HRS | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 58 consists of all product under product code: HRS and same usage:
Item no:
234800904 PROXIMAL DORSAL ULNA PLT
234800906 PROXIMAL DORSAL ULNA PLT
234800908 PROXIMAL DORSAL ULNA PLT
234800910 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.