BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bi-metric Ccocr Head/neck Replacement System.

Pre-market Notification Details

• Device ID: K992058
• 510k Number: K992058
• Device Name: BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Contact: Mary L Verstynen
• Correspondent: Mary L Verstynen; BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-18
• Decision Date: 1999-07-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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