Cleared Traditional

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS

K120360 · Ortho Solutions Limited · Orthopedic
May 2012
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K120360 is an FDA 510(k) clearance for the ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Ortho Solutions Limited (Prior Lake, US). The FDA issued a Cleared decision on May 29, 2012, 113 days after receiving the submission on February 6, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K120360 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2012
Decision Date May 29, 2012
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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