Real Intelligence ROB100021
Real Intelligence ROB100021 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K193120 on 14 Feb 2020 and listed in FDA GUDID since 1 May 2020 (UDI-DI 00885556774144), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00885556774144 | Date1 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193120 | Date14 Feb 2020 | StatusActive |
Official records
- AccessGUDID record 00885556774144
- FDA 510(k) database K193120
Across registries
- FDA 510(k) K193120 decided 14 Feb 2020 Active
- FDA GUDID UDI-DI 00885556774144 listed 1 May 2020 Listed
Timeline
- Cleared FDA 510(k) K193120
- Listed FDA GUDID 00885556774144
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Real Intelligence
- Generic name
- Optical surgical navigation/tracking system workstation, mobile
- Model / Ref / Catalog
- ROB100021
- Primary DI / UDI-DI
- 00885556774144
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Optical surgical navigation/tracking system workstation, mobile
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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