Cleared Traditional

Metal Bone Screw

K220921 · Double Medical Technology, Inc. · Orthopedic
Dec 2022
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K220921 is an FDA 510(k) clearance for the Metal Bone Screw, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on December 12, 2022, 257 days after receiving the submission on March 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K220921 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2022
Decision Date December 12, 2022
Days to Decision 257 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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