Cleared Special

DOMINATOR

K072127 · Biocomposites, Ltd. · Orthopedic
Aug 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K072127 is an FDA 510(k) clearance for the DOMINATOR, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on August 31, 2007, 29 days after receiving the submission on August 2, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K072127 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2007
Decision Date August 31, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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