MAESTRO WRIST FRACTURE IMPLANT

Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Maestro Wrist Fracture Implant.

Pre-market Notification Details

• Device ID: K080426
• 510k Number: K080426
• Device Name: MAESTRO WRIST FRACTURE IMPLANT
• Classification: Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: JWJ
• CFR Regulation Number: 888.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-20
• Decision Date: 2008-07-29
• Summary: summary

NIH GUDID Devices

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