SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM— 510(k) K130126

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K130126 for SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM, Substantially Equivalent on 2013-08-06. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2013-01-17
Decision date: 2013-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

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.