Cleared Traditional

CONMED LINVATEC INTERCEPT IMPLANT

K092998 · Linvatec Corp. · Orthopedic
Dec 2009
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K092998 is an FDA 510(k) clearance for the CONMED LINVATEC INTERCEPT IMPLANT, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on December 23, 2009, 86 days after receiving the submission on September 28, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K092998 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date December 23, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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