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FDA 510(k)

Anatomic Bone Plate

K-Number: K221088 · 2023-01-18

ApplicantDouble Medical Technology, Inc.
Decision Date2023-01-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomic Bone Plate is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-18 under approval number K221088. 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 Anatomic Bone Plate?

Anatomic Bone Plate is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K221088.

When was Anatomic Bone Plate approved by the FDA?

Anatomic Bone Plate received FDA 510(k) clearance on 2023-01-18, under approval number K221088.

What company makes Anatomic Bone Plate?

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

What is the FDA product code for Anatomic Bone Plate?

The FDA product code for Anatomic Bone Plate is HRS.

Related Clinical Trials

NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING

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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