Cleared Traditional

INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD

K920968 · Dow Corning Wright · Orthopedic

May 1993

Decision

429d

Days

Class 2

Risk

About This 510(k) Submission

K920968 is an FDA 510(k) clearance for the INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD, 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 5, 1993, 429 days after receiving the submission on March 2, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K920968 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1992
Decision Date	May 05, 1993
Days to Decision	429 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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