MODUILAR UNIPOLAR

Prosthesis, Hip, Femoral, Resurfacing

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Moduilar Unipolar.

Pre-market Notification Details

• Device ID: K950998
• 510k Number: K950998
• Device Name: MODUILAR UNIPOLAR
• Classification: Prosthesis, Hip, Femoral, Resurfacing
• Applicant: INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752
• Contact: Joann Ringer-kuhne
• Correspondent: Joann Ringer-kuhne; INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752
• Product Code: KXA
• CFR Regulation Number: 888.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-03
• Decision Date: 1995-04-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024170155	K950998	000
00889024169968	K950998	000
00889024169951	K950998	000
00889024169944	K950998	000
00889024169937	K950998	000
00889024183360	K950998	000
00889024183353	K950998	000
00889024183346	K950998	000
00889024183339	K950998	000
00889024183322	K950998	000
00889024183315	K950998	000
00889024183308	K950998	000
00889024183285	K950998	000
00889024183278	K950998	000
00889024170193	K950998	000
00889024170186	K950998	000
00889024170179	K950998	000
00889024169975	K950998	000
00889024169982	K950998	000
00889024170148	K950998	000
00889024170131	K950998	000
00889024170124	K950998	000
00889024170117	K950998	000
00889024170100	K950998	000
00889024170094	K950998	000
00889024170087	K950998	000
00889024170070	K950998	000
00889024170063	K950998	000
00889024170056	K950998	000
00889024170049	K950998	000
00889024170032	K950998	000
00889024170025	K950998	000
00889024170018	K950998	000
00889024170001	K950998	000
00889024169999	K950998	000
00889024170162	K950998	000