RINGLOC + HYBRID ACETABULAR SYSTEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Ringloc + Hybrid Acetabular System.

Pre-market Notification Details

• Device ID: K093235
• 510k Number: K093235
• Device Name: RINGLOC + HYBRID ACETABULAR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Gary Baker
• Correspondent: Gary Baker; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-15
• Decision Date: 2010-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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