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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 the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) 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. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221150.

When did Advanced Bone Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for Advanced Bone Plate?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Bone Plate?

The FDA product code for Advanced Bone Plate is HRS.

Other records listing Double Medical Technology, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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