ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE— 510(k) K953714

Substantially Equivalent for Some Indications

Zimmer, Inc.

FDA 510(k) clearance K953714 for ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE, Substantially Equivalent for Some Indications on 1995-11-20. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1995-08-09
Decision date: 1995-11-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code HRS

product code HRS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.