ATEC Alignment App
510(k) K211987
ATEC Alignment App is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Alphatec Spine, Inc., cleared under FDA 510(k) K211987 on 29 Oct 2021, 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 | FDA 510(k)SESE | NumberK211987 | Date29 Oct 2021 | StatusActive |
Official records
- FDA 510(k) database K211987
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K211987
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VEA AIX21000 | AIX21000 | 00190376470351 | — | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- syngo Application Software by SIEMENS MEDICAL SOLUTIONS USA, INC.
- KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM by Acuson Corp.
- PACSSTATION by Fernandez Industries, Inc.
- MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM by Barco NV Display Systems
- SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS by Fujifilm Medical System U.S.A., Inc.
- SmartTarget by Smarttarget, Ltd.
- SYNGO MBF by SIEMENS MEDICAL SOLUTIONS USA, INC.
- KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT by Kodak Health Imaging Systems, Inc.
- CENTRICITY PACS SYSTEM by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) by JVCKENWOOD Corporation