NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE— 510(k) K120772

Clearance details

Applicant

Zimmer GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2012-03-14

Decision date

2012-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0330-2020 — Connection Screw for NCB Plate, Item No. 0202266002Class II·Terminated·Zimmer Biomet, Inc.·20191010
• Z-0338-2020 — cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001Class II·Terminated·Zimmer Biomet, Inc.·20191010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120772.