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RPS Primary TKA Software +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K251971
Identifiers
- 510(k) Number
- K251971 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
- Models / Variants
- RPS Primary TKA Software FDA 510(k)RPS Console FDA 510(k)RPS Saw One FDA 510(k)RPS Cable FDA 510(k)RPS Saw Oscillating Tip Cartridge FDA 510(k)RPS Console Cart Attachment FDA 510(k)Ball Tip Pointer FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RPS Primary TKA Software +6 more models by Stryker Instruments — Class II — FDA_510K — listed in FDA 510(k) — 7 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251971 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K251971 24 fields · synced Jun 18, 2026