POROUS COATED ACETABULAR COMPONENTS

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 Porous Coated Acetabular Components.

Pre-market Notification Details

• Device ID: K050124
• 510k Number: K050124
• Device Name: POROUS COATED ACETABULAR COMPONENTS
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Beres
• Correspondent: Patricia Beres; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: MAY
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-19
• Decision Date: 2005-10-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00880304195011	K050124	000
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