K252897
- 510(k) number
- K252897
- Device name
- 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
- Applicant
- A Plus Biotechnology Co., Ltd. TW
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-12-11
- Date received
- 2025-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252897.pdf
Official FDA record: K252897
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.