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A Plus Biotechnology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories1
Latest Approval2026-03-17
TypeNumberDevice NameCodeDate
510(k) K254053 APS Spear Locking Plate HRS 2026-03-17 View
510(k) K252897 APS 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 HRS 2025-12-11 View
510(k) K223150 APS Metal Plate & Screw System HRS 2023-08-24 View