APR ACETABULAR INSERT

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

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Acetabular Insert.

Pre-market Notification Details

• Device ID: K941617
• 510k Number: K941617
• Device Name: APR ACETABULAR INSERT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Contact: Barry J Hassett
• Correspondent: Barry J Hassett; INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-04
• Decision Date: 1994-10-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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