Primary Device ID | 00190376470351 |
NIH Device Record Key | 7f7fd0ca-db18-4ddc-a1ad-e982a1e53e84 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VEA |
Version Model Number | AIX21000 |
Company DUNS | 602465783 |
Company Name | ALPHATEC SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190376470351 [Primary] |
LLZ | System, image processing, radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-07 |
Device Publish Date | 2022-06-29 |
00190376661612 - Valence Robotic Navigation System | 2025-04-21 Easy Lock Socket |
00190376661629 - Valence Robotic Navigation System | 2025-04-21 Allen Flex Frame Accessory Rail, 6.0 in |
00190376661636 - Valence Robotic Navigation System | 2025-04-21 Left Offset Accessory Rail Clamp |
00190376661643 - Valence Robotic Navigation System | 2025-04-21 Right Offset Accessory Rail Clamp |
00190376596419 - Pediatric Patient Positioner | 2025-04-15 LATERAL PUSH ARM |
00190376603438 - Pediatric Patient Positioner | 2025-04-15 T-HANDLE, LATERAL ARM |
00190376603582 - Pediatric Patient Positioner | 2025-04-15 Lateral Push Arm Pad |
00190376675695 - Pediatric Patient Positioner | 2025-04-15 BETA Pediatric Patient Positioner Lateral Arm |