OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM— 510(k) K093761

Substantially Equivalent

Biomet Trauma (Aka Ebi, Lp)

FDA 510(k) clearance K093761 for OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM, Substantially Equivalent on 2010-03-05. Applicant: Biomet Trauma (Aka Ebi, Lp).

Clearance details

Applicant: Biomet Trauma (Aka Ebi, Lp)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2009-12-07
Decision date: 2010-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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.