Cleared Traditional

Advanced Bone Plate

K221150 · Double Medical Technology, Inc. · Orthopedic
Jan 2023
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K221150 is an FDA 510(k) clearance for the Advanced Bone Plate, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on January 25, 2023, 280 days after receiving the submission on April 20, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221150 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2022
Decision Date January 25, 2023
Days to Decision 280 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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