RIM-FIX, ACETABULAR CUP

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

SURGICAL IMPLANTS INC.

The following data is part of a premarket notification filed by Surgical Implants Inc. with the FDA for Rim-fix, Acetabular Cup.

Pre-market Notification Details

• Device ID: K993713
• 510k Number: K993713
• Device Name: RIM-FIX, ACETABULAR CUP
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: SURGICAL IMPLANTS INC. 962 SOUTH TAMIAMI TRAIL Sarasota, FL 34236
• Contact: Douglas W Stuart
• Correspondent: Douglas W Stuart; SURGICAL IMPLANTS INC. 962 SOUTH TAMIAMI TRAIL Sarasota, FL 34236
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-03
• Decision Date: 2000-01-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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