K251971
- 510(k) number
- K251971
- Device name
- RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
- Applicant
- Stryker Instruments MI · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-09-25
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251971.pdf
Official FDA record: K251971
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.