Cleared Traditional

MATRYX INTERFERENCE SCREW (5.0-6.5MM)

K102410 · Conmed Linvatec · Orthopedic
Dec 2010
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K102410 is an FDA 510(k) clearance for the MATRYX INTERFERENCE SCREW (5.0-6.5MM), a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on December 21, 2010, 119 days after receiving the submission on August 24, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K102410 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2010
Decision Date December 21, 2010
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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