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FDA 510(k)

APS Metal Plate & Screw System

K-Number: K223150 · 2023-08-24

ApplicantA Plus Biotechnology Co., Ltd.
Decision Date2023-08-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APS Metal Plate & Screw System is the device name listed in this FDA 510(k) record. The listed applicant is A Plus Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K223150. 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 APS Metal Plate & Screw System?

APS Metal Plate & Screw System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K223150.

When did APS Metal Plate & Screw System receive FDA 510(k) clearance?

APS Metal Plate & Screw System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K223150.

Who is the listed applicant for APS Metal Plate & Screw System?

The FDA 510(k) record lists A Plus Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APS Metal Plate & Screw System?

The FDA product code for APS Metal Plate & Screw System is HRS.

Other records listing A Plus Biotechnology Co., Ltd. as applicant

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.

K254053APS Spear Locking PlateK252897APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista

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

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

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