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FDA 510(k)

Advanced Bone Plate

K-Number: K221150 · 2023-01-25

ApplicantDouble Medical Technology, Inc.
Decision Date2023-01-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Advanced Bone Plate is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-25 under approval number K221150. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced Bone Plate?

Advanced Bone Plate is a medical device that received FDA 510(k) clearance on 2023-01-25. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K221150.

When was Advanced Bone Plate approved by the FDA?

Advanced Bone Plate received FDA 510(k) clearance on 2023-01-25, under approval number K221150.

What company makes Advanced Bone Plate?

Advanced Bone Plate is manufactured by Double Medical Technology, Inc..

What is the FDA product code for Advanced Bone Plate?

The FDA product code for Advanced Bone Plate is HRS.

Other Devices by Double Medical Technology, Inc.

K151458Double Medical Universal Spine System K172830Double Medical Femoral Nail System K172828Double Medical Cage System K221221Advanced Intramedullary Nail System K220921Metal Bone Screw K233078Posterior Cervical Spine System

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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