Cleared Traditional

AUTO-DRIVE LAG SCREW SYSTEM

K010964 · Osteomed Corp. · Orthopedic
Jul 2001
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K010964 is an FDA 510(k) clearance for the AUTO-DRIVE LAG SCREW SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on July 5, 2001, 97 days after receiving the submission on March 30, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K010964 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2001
Decision Date July 05, 2001
Days to Decision 97 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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