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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 a medical device manufactured by A Plus Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under approval 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. It is manufactured by A Plus Biotechnology Co., Ltd.. The 510(k) number is K223150.

When was APS Metal Plate & Screw System approved by the FDA?

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

What company makes APS Metal Plate & Screw System?

APS Metal Plate & Screw System is manufactured by A Plus Biotechnology Co., Ltd..

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

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

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Other Devices by A Plus Biotechnology Co., Ltd.

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 K254053APS Spear Locking Plate

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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