SLEEVE WITH ZIPLOOP FIXATION DEVICES— 510(k) K101063

Substantially Equivalent

Biomet Sports Medicine

FDA 510(k) clearance K101063 for SLEEVE WITH ZIPLOOP FIXATION DEVICES, Substantially Equivalent on 2010-06-23. Applicant: Biomet Sports Medicine.

Clearance details

Applicant: Biomet Sports Medicine
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2010-04-16
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.