Cleared Traditional

CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY

K080531 · Conmed Linvatec · General Hospital

Sep 2008

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K080531 is an FDA 510(k) clearance for the CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on September 5, 2008, 192 days after receiving the submission on February 26, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K080531 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2008
Decision Date	September 05, 2008
Days to Decision	192 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850