Cleared Traditional

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS

K111678 · Ortho Solutions Limited · Orthopedic
Feb 2012
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K111678 is an FDA 510(k) clearance for the ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS 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 February 7, 2012, 237 days after receiving the submission on June 15, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K111678 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2011
Decision Date February 07, 2012
Days to Decision 237 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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