Cleared Special

MODIFICATION TO BILOK ST SCREW

K071115 · Biocomposites, Ltd. · Orthopedic
May 2007
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K071115 is an FDA 510(k) clearance for the MODIFICATION TO BILOK ST SCREW, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on May 17, 2007, 27 days after receiving the submission on April 20, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K071115 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2007
Decision Date May 17, 2007
Days to Decision 27 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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