Explorer TO ET1-302812
by SeaSpine Orthopedics Corporation
Explorer TO ET1-302812 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 10889981206543), 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 | Number10889981206543 | Date1 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193418 | Date13 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 10889981206543
- FDA 510(k) database K193418
Across registries
- FDA 510(k) K193418 decided 13 Mar 2020 Active
- FDA GUDID UDI-DI 10889981206543 listed 1 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K193418
- Listed FDA GUDID 10889981206543
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Explorer TO
- Generic name
- Metal-polymer composite spinal interbody fusion cage
- Model / Ref / Catalog
- ET1-302812
- Primary DI / UDI-DI
- 10889981206543
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Metal-polymer composite spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).
- NuVasive Cohere Thoracolumbar Interbody System by Nu Vasive, Incorporated
- SIRION Lateral Lumbar Interbody System by Astura Medical
- JULIET ® Ti LL JLT-MY 40 16-S by Spineart
- Catalyft PL Expandable Interbody System 6069116 by MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System 6069113 by MEDTRONIC SOFAMOR DANEK, INC.
- JULIET ® Ti LL JLT-MX 50 12-S by Spineart
- FlareHawk CMP-00111 FHPAS30023X by Integrity Implants Inc.
- LDR SPINE ROI INTERBODY FUSION SYSTEM by Ldr Spine USA
- ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD by Advanced Vertebral Solutions, LLC
- X-PAC® LLIF Expandable Lateral Cage System by Expanding Innovations, Inc.