S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL

About This 510(k) Submission

K113409 is an FDA 510(k) clearance for the S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL, 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 February 15, 2012, 89 days after receiving the submission on November 18, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.