TRIDENT ACETABULAR SYSTEM

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 Acetabular System.

Pre-market Notification Details

• Device ID: K033716
• 510k Number: K033716
• Device Name: TRIDENT ACETABULAR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Denise Duchene
• Correspondent: Denise Duchene; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-26
• Decision Date: 2005-02-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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