Exceed™ Biplanar Expandable Interbody System 10-7706
Exceed™ Biplanar Expandable Interbody System 10-7706 is a Class II device made by Spine Wave, Inc., cleared under FDA 510(k) K231275 on 25 Jul 2023 and listed in FDA GUDID since 6 Nov 2025 (UDI-DI 10840642171532), 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 | Number10840642171532 | Date6 Nov 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231275 | Date25 Jul 2023 | StatusActive |
Official records
- AccessGUDID record 10840642171532
- FDA 510(k) database K231275
Across registries
- FDA 510(k) K231275 decided 25 Jul 2023 Active
- FDA GUDID UDI-DI 10840642171532 listed 6 Nov 2025 Listed
Timeline
- Cleared FDA 510(k) K231275
- Listed FDA GUDID 10840642171532
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Exceed™ Biplanar Expandable Interbody System
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / Ref / Catalog
- 10-7706
- Primary DI / UDI-DI
- 10840642171532
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization