APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr And Apr Ii Press-fit Universal Hip System.

Pre-market Notification Details

• Device ID: K905781
• 510k Number: K905781
• Device Name: APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-12-28
• Decision Date: 1991-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024174375	K905781	000
00889024174245	K905781	000
00889024174252	K905781	000
00889024174269	K905781	000
00889024174276	K905781	000
00889024174283	K905781	000
00889024174290	K905781	000
00889024174306	K905781	000
00889024174313	K905781	000
00889024174320	K905781	000
00889024174337	K905781	000
00889024174344	K905781	000
00889024174351	K905781	000
00889024174368	K905781	000
00889024174238	K905781	000