Cleared Traditional

LITTLE GRAFTER SCREW

K040265 · Biocomposites, Ltd. · Orthopedic
May 2004
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K040265 is an FDA 510(k) clearance for the LITTLE GRAFTER 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 May 28, 2004, 113 days after receiving the submission on February 5, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K040265 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2004
Decision Date May 28, 2004
Days to Decision 113 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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