SureMAX-X 1
by Additive Implants, Inc. 60 variants
SureMAX-X 1 (1802-07121406) is a Class II device made by Additive Implants, Inc., cleared under FDA 510(k) K193359 on 3 Jan 2020 and listed in FDA GUDID since 4 Mar 2020 (UDI-DI 00817662021225), active as of 22 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 | Number00817662021225 | Date4 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193359 | Date3 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 00817662021225
- FDA 510(k) database K193359
Across registries
- FDA 510(k) K193359 decided 3 Jan 2020 Active
- FDA GUDID UDI-DI 00817662021225 listed 4 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K193359
- Listed FDA GUDID 00817662021225
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SureMAX-X
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- 1, 1802-07121406
- Primary DI / UDI-DI
- 00817662021225
- 510(k) Number
- FDA product code
- ODP
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Angle — 7 degreeDepth — 12 MillimeterWidth — 14 MillimeterHeight — 6 Millimeter
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