Cleared Traditional

K925512 - CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
(FDA 510(k) Clearance)

K925512 · Dow Corning Wright · Orthopedic

Feb 1993

Decision

210d

Days

Class 2

Risk

K925512 is an FDA 510(k) clearance for the CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION. This device is classified as 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 February 12, 1993, 210 days after receiving the submission on July 17, 1992.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K925512 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 1992
Decision Date	February 12, 1993
Days to Decision	210 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