TRIDENT POROUS TITANIUM ACETABULAR COMPONENT

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

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trident Porous Titanium Acetabular Component.

Pre-market Notification Details

• Device ID: K010170
• 510k Number: K010170
• Device Name: TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Margaret F Crowe
• Correspondent: Margaret F Crowe; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-18
• Decision Date: 2001-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327025279	K010170	000
07613327025262	K010170	000
07613327025255	K010170	000
07613327025248	K010170	000