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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 a medical device manufactured by A Plus Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-17 under approval 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. It is manufactured by A Plus Biotechnology Co., Ltd.. The 510(k) number is K254053.

When was APS Spear Locking Plate approved by the FDA?

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

What company makes APS Spear Locking Plate?

APS Spear Locking Plate is manufactured by A Plus Biotechnology Co., Ltd..

What is the FDA product code for APS Spear Locking Plate?

The FDA product code for APS Spear Locking Plate is HRS.

Other Devices by A Plus Biotechnology Co., Ltd.

K223150APS Metal Plate & Screw System 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 / Dista

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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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