SureMAX 1
by Additive Implants, Inc. 84 variants
SureMAX 1 is a Class II device made by Additive Implants, Inc., cleared under FDA 510(k) K182477 on 28 Jan 2019 and listed in FDA GUDID since 21 Feb 2019 (UDI-DI 00817662021706), 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 | Number00817662021706 | Date21 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182477 | Date28 Jan 2019 | StatusActive |
Official records
- AccessGUDID record 00817662021706
- FDA 510(k) database K182477
Across registries
- FDA 510(k) K182477 decided 28 Jan 2019 Active
- FDA GUDID UDI-DI 00817662021706 listed 21 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K182477
- Listed FDA GUDID 00817662021706
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SureMAX
- Generic name
- Instrument tray, reusable
- Model / reference
- 1
- Primary DI / UDI-DI
- 00817662021706
- 510(k) Number
- FDA product code
- KCT
- GMDN term
- Instrument tray, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 21.13 InchWidth — 10 InchHeight — 3.28 Inch
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