COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM— 510(k) K112905

Substantially Equivalent

Biomet Orthopedics, LLC

FDA 510(k) clearance K112905 for COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM, Substantially Equivalent on 2012-05-24. Applicant: Biomet Orthopedics, LLC.

Clearance details

Applicant: Biomet Orthopedics, LLC
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2012-05-24
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.