Cleared Special

AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS

K100475 · Howmedica Osteonics Corp. · Orthopedic
Apr 2010
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K100475 is an FDA 510(k) clearance for the AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on April 30, 2010, 71 days after receiving the submission on February 18, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K100475 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2010
Decision Date April 30, 2010
Days to Decision 71 days
Submission Type Special
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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