WaveForm TA WA1-301010
by SeaSpine Orthopedics Corporation
WaveForm TA WA1-301010 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K210583 on 2 Jun 2021 and listed in FDA GUDID since 29 Nov 2024 (UDI-DI 10889981263676), 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 | Number10889981263676 | Date29 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210583 | Date2 Jun 2021 | StatusActive |
Official records
- AccessGUDID record 10889981263676
- FDA 510(k) database K210583
Across registries
- FDA 510(k) K210583 decided 2 Jun 2021 Active
- FDA GUDID UDI-DI 10889981263676 listed 29 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K210583
- Listed FDA GUDID 10889981263676
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WaveForm TA
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- WA1-301010
- Primary DI / UDI-DI
- 10889981263676
- FDA product code
- MAX, OVD
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
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