SureMAX 1
by Additive Implants, Inc. 84 variants
SureMAX 1 is a metallic spinal interbody fusion cage (FDA Class II; FDA product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical) made by Additive Implants, Inc., cleared under FDA 510(k) K182477 on 28 Jan 2019 and listed in FDA GUDID since 19 Feb 2019 (UDI-DI 00817662020013), 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 | Number00817662020013 | Date19 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182477 | Date28 Jan 2019 | StatusActive |
Official records
- AccessGUDID record 00817662020013
- FDA 510(k) database K182477
Across registries
- FDA 510(k) K182477 decided 28 Jan 2019 Active
- FDA GUDID UDI-DI 00817662020013 listed 19 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K182477
- Listed FDA GUDID 00817662020013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SureMAX
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 1
- Primary DI / UDI-DI
- 00817662020013
- 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
- Height — 6 MillimeterWidth — 14 MillimeterDepth — 12 MillimeterAngle — 7 degree
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