MODULAR HYBRID GLENOID

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Modular Hybrid Glenoid.

Pre-market Notification Details

• Device ID: K060694
• 510k Number: K060694
• Device Name: MODULAR HYBRID GLENOID
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-15
• Decision Date: 2006-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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