WaveForm A WA4-311010
by SeaSpine Orthopedics Corporation
WaveForm A WA4-311010 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K222732 on 7 Nov 2022 and listed in FDA GUDID since 24 Mar 2023 (UDI-DI 10889981304324), 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 | Number10889981304324 | Date24 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222732 | Date7 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 10889981304324
- FDA 510(k) database K222732
Across registries
- FDA 510(k) K222732 decided 7 Nov 2022 Active
- FDA GUDID UDI-DI 10889981304324 listed 24 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K222732
- Listed FDA GUDID 10889981304324
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WaveForm A
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- WA4-311010
- Primary DI / UDI-DI
- 10889981304324
- FDA product code
- OVD, MAX
- 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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