Cleared Traditional

1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM

K023260 · Osteomed Corp. · Orthopedic
Oct 2002
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K023260 is an FDA 510(k) clearance for the 1.2MM OSTEOMED AUTO-DRIVE 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 October 18, 2002, 18 days after receiving the submission on September 30, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K023260 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2002
Decision Date October 18, 2002
Days to Decision 18 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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