OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM

Plate, Fixation, Bone

BIOMET TRAUMA (AKA EBI, LP)

The following data is part of a premarket notification filed by Biomet Trauma (aka Ebi, Lp) with the FDA for Optilock Vl (variable Angle Locking) Distal Radius Plating System.

Pre-market Notification Details

• Device ID: K093761
• 510k Number: K093761
• Device Name: OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: BIOMET TRAUMA (AKA EBI, LP) 100 INTERPACE PARKWAY Parsippany, NJ 07054
• Contact: Margaret Crowe
• Correspondent: Margaret Crowe; BIOMET TRAUMA (AKA EBI, LP) 100 INTERPACE PARKWAY Parsippany, NJ 07054
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-07
• Decision Date: 2010-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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