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FDA 510(k)

APS Spear Locking Plate

K-Number: K254053 · 2026-03-17

ApplicantA Plus Biotechnology Co., Ltd.
Decision Date2026-03-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APS Spear Locking Plate 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 2026-03-17 under 510(k) number K254053. 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 Spear Locking Plate?

APS Spear Locking Plate is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K254053.

When did APS Spear Locking Plate receive FDA 510(k) clearance?

APS Spear Locking Plate received FDA 510(k) clearance on 2026-03-17, under 510(k) number K254053.

Who is the listed applicant for APS Spear Locking Plate?

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 Spear Locking Plate?

The FDA product code for APS Spear Locking Plate 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.

K252897APS 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 / DistaK223150APS Metal Plate & Screw System

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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