Cleared Traditional

BILOK ST SCREW

K033792 · Biocomposites, Ltd. · Orthopedic
Mar 2004
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K033792 is an FDA 510(k) clearance for the BILOK ST SCREW, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on March 1, 2004, 87 days after receiving the submission on December 5, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K033792 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2003
Decision Date March 01, 2004
Days to Decision 87 days
Submission Type Traditional
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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