FDA 510(k) Applications Submitted by Sandy Gill
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K200995 |
04/16/2020 |
InsigniaÖ Anterior Cervical Plate System |
Alphatec Spine, Inc. |
K211805 |
06/11/2021 |
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System |
Alphatec Spine, Inc. |
K221821 |
06/23/2022 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc. |
K232173 |
07/21/2023 |
Ascend VBR System, Ascend NanoTec VBR System |
Alphatec Spine, Inc. |
K202327 |
08/17/2020 |
InvictusÖ OsseoScrew« System |
Alphatec Spine, Inc. |
K202587 |
09/08/2020 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
K213443 |
10/25/2021 |
InsigniaÖ Anterior Cervical Plate System |
Alphatec Spine, Inc. |
K213460 |
10/27/2021 |
Invictus Spinal Fixation System |
Alphatec Spine, Inc. |
K223765 |
12/15/2022 |
ATEC Lateral Navigation Instruments |
Alphatec Spine, Inc. |
K214006 |
12/22/2021 |
Invictus« Spinal Fixation System |
Alphatec Spine, Inc. |
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