510(k) K252897 ยท HRS Plate, Fixation, Bone
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 Tib
| Applicant | A Plus Biotechnology Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Dec 11, 2025 |
| Received | Sep 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252897
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.