Cleared Traditional

PINN-ACL CROSSPIN

K043106 · Linvatec Corp. · Orthopedic
Jan 2005
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K043106 is an FDA 510(k) clearance for the PINN-ACL CROSSPIN, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on January 19, 2005, 71 days after receiving the submission on November 9, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K043106 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2004
Decision Date January 19, 2005
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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