Cleared Traditional

K941534 - MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
(FDA 510(k) Clearance)

K941534 · 3M Health Care, Ltd. · Orthopedic

Mar 1995

Decision

341d

Days

Class 2

Risk

K941534 is an FDA 510(k) clearance for the MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY).

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 6, 1995, 341 days after receiving the submission on March 30, 1994.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K941534 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 1994
Decision Date	March 06, 1995
Days to Decision	341 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390