ExactechGPS Diamond Tracker2 T
ExactechGPS Diamond Tracker2 T (A00205) is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K213877 on 2 May 2022 and listed in FDA GUDID since 21 Jun 2022 (UDI-DI 10885862607188), 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 | Number10885862607188 | Date21 Jun 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213877 | Date2 May 2022 | StatusActive |
Official records
- AccessGUDID record 10885862607188
- FDA 510(k) database K213877
Across registries
- FDA 510(k) K213877 decided 2 May 2022 Active
- FDA GUDID UDI-DI 10885862607188 listed 21 Jun 2022 Listed
Timeline
- Cleared FDA 510(k) K213877
- Listed FDA GUDID 10885862607188
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ExactechGPS
- Generic name
- Robotic surgical navigation system
- Model / Ref / Catalog
- Diamond Tracker2 T, A00205
- Primary DI / UDI-DI
- 10885862607188
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Robotic surgical navigation system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Robotic surgical navigation system.