Robotic Frame Connection Kit KIT0899-04
Robotic Frame Connection Kit KIT0899-04 is a Class II device made by Mazor Robotics Ltd, cleared under FDA 510(k) K203005 on 27 Oct 2020 (1 earlier submission) and listed in FDA GUDID since 18 May 2021 (UDI-DI 07290109184784), active as of 9 Nov 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290109184784 | Date18 May 2021 | StatusListed |
| United States | FDA 510(k) | NumberK203005 | Date27 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 07290109184784
- FDA 510(k) database K203005
- FDA 510(k) database K200935
Across registries
- FDA 510(k) K203005 decided 27 Oct 2020 Active
- FDA GUDID UDI-DI 07290109184784 listed 18 May 2021 Listed
Recalls
-
- Ongoing Z-0101-2024
Software update
Timeline
- Cleared FDA 510(k) K200935
- Cleared FDA 510(k) K203005
- Listed FDA GUDID 07290109184784
- Recall initiated FDA recalls Z-0101-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Robotic Frame Connection Kit
- Generic name
- Stereotactic surgery system probe, reusable
- Model / reference
- KIT0899-04
- Primary DI / UDI-DI
- 07290109184784
- FDA product code
- OLO, LLZ
- GMDN term
- Stereotactic surgery system probe, reusable
- Device class
- Class II
- Regulation number
- 882.4560, 892.2050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Stereotactic surgery system probe, reusable.