Cleared Traditional

CORTICAL BONE SCREWS

K872738 · Military Engineering, Inc. · Orthopedic
Jul 1987
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K872738 is an FDA 510(k) clearance for the CORTICAL BONE SCREWS, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 30, 1987, 20 days after receiving the submission on July 10, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K872738 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1987
Decision Date July 30, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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