Calibrate 320-07102500
Calibrate 320-07102500 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K211873 on 10 Aug 2021 and listed in FDA GUDID since 22 Jan 2022 (UDI-DI 00190376321585), 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 | Number00190376321585 | Date22 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211873 | Date10 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 00190376321585
- FDA 510(k) database K211873
Across registries
- FDA 510(k) K211873 decided 10 Aug 2021 Active
- FDA GUDID UDI-DI 00190376321585 listed 22 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K211873
- Listed FDA GUDID 00190376321585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Calibrate
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 320-07102500
- Primary DI / UDI-DI
- 00190376321585
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Angle — 20 degreeHeight — 7 MillimeterWidth — 10 MillimeterLength — 25 Millimeter