RANAWAT/BURSTEIN TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ranawat/burstein Total Hip System.

Pre-market Notification Details

• Device ID: K921277
• 510k Number: K921277
• Device Name: RANAWAT/BURSTEIN TOTAL HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587
• Contact: Patricia Beres
• Correspondent: Patricia Beres; BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-17
• Decision Date: 1994-02-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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