Cleared Traditional

TRIDENT T ACETABULAR SHELLS

K040412 · Stryker Orthopaedics · Orthopedic

May 2004

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K040412 is an FDA 510(k) clearance for the TRIDENT T ACETABULAR SHELLS, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on May 25, 2004, 97 days after receiving the submission on February 18, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K040412 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2004
Decision Date	May 25, 2004
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358