Cleared Traditional

T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES

K102992 · Howmedica Osteonics Corp. · Orthopedic
Dec 2010
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K102992 is an FDA 510(k) clearance for the T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on December 22, 2010, 75 days after receiving the submission on October 8, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K102992 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2010
Decision Date December 22, 2010
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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