Explorer TO ET2-001000
by SeaSpine Orthopedics Corporation
Explorer TO ET2-001000 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K193418 on 13 Mar 2020 and listed in FDA GUDID since 1 Sep 2020 (UDI-DI 10889981207137), 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 | Number10889981207137 | Date1 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193418 | Date13 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 10889981207137
- FDA 510(k) database K193418
Across registries
- FDA 510(k) K193418 decided 13 Mar 2020 Active
- FDA GUDID UDI-DI 10889981207137 listed 1 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K193418
- Listed FDA GUDID 10889981207137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Explorer TO
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- ET2-001000
- Primary DI / UDI-DI
- 10889981207137
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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