Device details
FDA 510(k) registration fields
- K number
- K233256
- Device name
- Robotic Integration Instruments
- Company
- DePuy Synthes
- Country / Region
- Switzerland(CH)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-09-28
- Decision date
- 2024-06-17
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryRobotic AssistanceNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
