ARCPM 1050 RESIN-HIPS

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

BIOMET ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Arcpm 1050 Resin-hips.

Pre-market Notification Details

• Device ID: K023357
• 510k Number: K023357
• Device Name: ARCPM 1050 RESIN-HIPS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw, IN 46582
• Contact: Tracy J Bickel
• Correspondent: Tracy J Bickel; BIOMET ORTHOPEDICS, INC. 56 EAS BELL DR. P.O. BOX 587 Warsaw, IN 46582
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-07
• Decision Date: 2002-11-06
• Summary: summary

NIH GUDID Devices

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