Cleared Traditional

BIOLOK SCREW

K002070 · Biocomposites, Ltd. · Orthopedic
Aug 2000
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K002070 is an FDA 510(k) clearance for the BIOLOK 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 August 25, 2000, 49 days after receiving the submission on July 7, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K002070 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2000
Decision Date August 25, 2000
Days to Decision 49 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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