BIOMET TIBIAL LOCKING NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Tibial Locking Nail System.

Pre-market Notification Details

• Device ID: K063570
• 510k Number: K063570
• Device Name: BIOMET TIBIAL LOCKING NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Becky Earl
• Correspondent: Becky Earl; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-29
• Decision Date: 2007-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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