Cleared Traditional

K932222 - SLT FEMORAL HEAD
(FDA 510(k) Clearance)

K932222 · Dow Corning Wright · Orthopedic

May 1994

Decision

385d

Days

Class 2

Risk

K932222 is an FDA 510(k) clearance for the SLT FEMORAL HEAD, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on May 27, 1994, 385 days after receiving the submission on May 7, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K932222 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 1993
Decision Date	May 27, 1994
Days to Decision	385 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353