APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE

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

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr(r) Hip Syst & Natural-hip(r) For Uncement Use.

Pre-market Notification Details

• Device ID: K920955
• 510k Number: K920955
• Device Name: APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Contact: Webb
• Correspondent: Webb; INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-02-26
• Decision Date: 1994-02-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024178014	K920955	000
00889024457867	K920955	000