Calibrate LTX Interbody System
Alphatec Spine, Inc.
ALPHATEC SPINE, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2027467 | 2027467 | ALPHATEC SPINE, INC. | 1 | Y | 2026-01-01 | 1950 Camino Vida Roble Carlsbad CA US 92008 |
| 3015537048 | 3015537048 | ALPHATEC SPINE, INC. | 1 | N | 2026-01-01 | 168 Centennial Parkway Unit 170 Louisville CO US 80027 |
| 3019878714 | 3019878714 | Alphatec Spine, Inc. | 1 | Y | 2026-01-01 | 4101 Willow Lake Blvd. Memphis TN US 38118 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 295423 | 2066960189 | K253615 | Invictus Bands System | OWI | 2026-03-25 |
| 145220 | 2066960189 | K253615 | Invictus Bands System | OWI | 2026-03-25 |
| 295423 | 1268104771 | K252842 | SafeOp 3: Neural Informatix System | GWF | 2026-01-11 |
| 145220 | 1268104771 | K252842 | SafeOp 3: Neural Informatix System | GWF | 2026-01-11 |
| 317303 | 1884662717 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | 2026-02-19 |
| 295423 | 1884662717 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | 2026-02-19 |
| 145220 | 1884662717 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | 2026-02-19 |
| 145220 | 1021457875 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | 2025-08-28 |
| 295423 | 1021457875 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | 2025-08-28 |
| 295423 | 1335595036 | K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | OVD | 2025-09-03 |
| 145220 | 1335595036 | K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | OVD | 2025-09-03 |
| 295423 | 1144623766 | K251080 | IdentiTi II Cervical Interbody System | ODP | 2025-07-03 |
| 145220 | 1144623766 | K251080 | IdentiTi II Cervical Interbody System | ODP | 2025-07-03 |
| 295423 | 1703624306 | K243461 | Calibrate Interbody Systems | 2025-03-04 | |
| 145220 | 1703624306 | K243461 | Calibrate Interbody Systems | 2025-03-04 | |
| 295423 | 1596212009 | K242364 | IdentiTi II Interbody System | MAX | 2024-10-04 |
| 145220 | 1596212009 | K242364 | IdentiTi II Interbody System | MAX | 2024-10-04 |
| 295423 | 1657673837 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | MAX | 2024-09-20 |
| 145220 | 1657673837 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | MAX | 2024-09-20 |
| 295423 | 2021134546 | K241519 | Invictus® Small Stature Spinal Fixation System | NKB | 2024-06-21 |
| 145220 | 2021134546 | K241519 | Invictus® Small Stature Spinal Fixation System | NKB | 2024-06-21 |
| 295423 | 1515473944 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | MAX | 2025-02-03 |
| 145220 | 1515473944 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | MAX | 2025-02-03 |
| 295423 | 1674405586 | K240951 | Invictus Robotic Navigation Instruments | OLO | 2024-06-06 |
| 145220 | 1674405586 | K240951 | Invictus Robotic Navigation Instruments | OLO | 2024-06-06 |
| 145220 | 1708200719 | K240199 | IntraOp Alignment System | OWB | 2024-05-22 |
| 295423 | 1708200719 | K240199 | IntraOp Alignment System | OWB | 2024-05-22 |
| 145220 | 1162926625 | K234092 | SafeOp 3: Neural Informatix Systeem | GWF | 2024-04-19 |
| 295423 | 1162926625 | K234092 | SafeOp 3: Neural Informatix Systeem | GWF | 2024-04-19 |
| 295423 | 1652591647 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | KWQ | 2024-02-22 |
| 145220 | 1652591647 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | KWQ | 2024-02-22 |
| 145220 | 1860894521 | K232504 | Calibrate CCX Interbody System | MAX | 2023-10-13 |
| 295423 | 1860894521 | K232504 | Calibrate CCX Interbody System | MAX | 2023-10-13 |
| 317303 | 1097824337 | K232413 | Fusion Robotic Navigation System | OLO | 2023-09-08 |
| 295423 | 1097824337 | K232413 | Fusion Robotic Navigation System | OLO | 2023-09-08 |
| 145220 | 1097824337 | K232413 | Fusion Robotic Navigation System | OLO | 2023-09-08 |
| 295423 | 2041361775 | K232345 | ATEC Posterior Navigated Disc Prep Instruments | OLO | 2023-11-02 |
| 145220 | 2041361775 | K232345 | ATEC Posterior Navigated Disc Prep Instruments | OLO | 2023-11-02 |
| 295423 | 1907160548 | K232275 | Invictus® Spinal Fixation System | NKB | 2023-09-27 |
| 145220 | 1907160548 | K232275 | Invictus® Spinal Fixation System | NKB | 2023-09-27 |
| 295423 | 1021311455 | K232173 | Ascend VBR System, Ascend NanoTec VBR System | MQP | 2023-10-06 |
| 145220 | 1021311455 | K232173 | Ascend VBR System, Ascend NanoTec VBR System | MQP | 2023-10-06 |
| 295423 | 1109609323 | K232097 | IdentiTi ALIF Interbody Systems | OVD | 2023-09-25 |
| 145220 | 1109609323 | K232097 | IdentiTi ALIF Interbody Systems | OVD | 2023-09-25 |
| 295423 | 1647860321 | K232044 | Invictus Robotic Navigation Instruments | OLO | 2023-10-06 |
| 145220 | 1647860321 | K232044 | Invictus Robotic Navigation Instruments | OLO | 2023-10-06 |
| 145220 | 1631327503 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | MAX | 2023-07-13 |
| 295423 | 1631327503 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | MAX | 2023-07-13 |
| 145220 | 1397030438 | K230721 | ATEC Lateral Plate System | KWQ | 2023-05-09 |
| 295423 | 1237491306 | K223765 | ATEC Lateral Navigation Instruments | OLO | 2023-03-23 |
| 145220 | 1237491306 | K223765 | ATEC Lateral Navigation Instruments | OLO | 2023-03-23 |
| 295423 | 1781725591 | K223611 | Calibrate LTX Interbody System | MAX | 2023-03-29 |
| 145220 | 1781725591 | K223611 | Calibrate LTX Interbody System | MAX | 2023-03-29 |
| 317303 | 1502393906 | K223350 | Remi Robotic Navigation System | OLO | 2023-03-13 |
| 295423 | 1502393906 | K223350 | Remi Robotic Navigation System | OLO | 2023-03-13 |
| 145220 | 1502393906 | K223350 | Remi Robotic Navigation System | OLO | 2023-03-13 |
| 145220 | 1758776921 | K223070 | Remi Robotic Navigation System | OLO | 2022-10-28 |
| 295423 | 1758776921 | K223070 | Remi Robotic Navigation System | OLO | 2022-10-28 |
| 317303 | 1758776921 | K223070 | Remi Robotic Navigation System | OLO | 2022-10-28 |
| 295423 | 1034029589 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | ODP | 2022-11-17 |
| 145220 | 1034029589 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | ODP | 2022-11-17 |
| 295423 | 1387247108 | K222455 | Calibrate LTX Interbody System | MAX | 2022-11-18 |
| 145220 | 1387247108 | K222455 | Calibrate LTX Interbody System | MAX | 2022-11-18 |
| 295423 | 1730566642 | K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | MAX | 2022-10-07 |
| 145220 | 1730566642 | K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | MAX | 2022-10-07 |
| 295423 | 1238203023 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | PML | 2022-12-20 |
| 145220 | 1238203023 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | PML | 2022-12-20 |
| 295423 | 1126377593 | K221821 | ATEC IOM Accessory Instruments | PDQ | 2022-09-23 |
| 145220 | 1126377593 | K221821 | ATEC IOM Accessory Instruments | PDQ | 2022-09-23 |
| 295423 | 1696859843 | K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | MAX | 2022-06-09 |
| 145220 | 1696859843 | K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | MAX | 2022-06-09 |
| 295423 | 2031094078 | K214006 | Invictus® Spinal Fixation System | NKB | 2022-04-04 |
| 145220 | 2031094078 | K214006 | Invictus® Spinal Fixation System | NKB | 2022-04-04 |
| 295423 | 1844531527 | K213849 | SafeOp 2: Neural Informatix System | GWF | 2022-03-09 |
| 145220 | 1844531527 | K213849 | SafeOp 2: Neural Informatix System | GWF | 2022-03-09 |
| 295423 | 1717203489 | K213460 | Invictus Spinal Fixation System | NKB | 2021-12-10 |
| 145220 | 1717203489 | K213460 | Invictus Spinal Fixation System | NKB | 2021-12-10 |
| 295423 | 1260756728 | K213443 | Insignia Anterior Cervical Plate System | KWQ | 2021-12-15 |
| 145220 | 1260756728 | K213443 | Insignia Anterior Cervical Plate System | KWQ | 2021-12-15 |
| 145220 | 1784738252 | K211987 | ATEC Alignment App | LLZ | 2021-10-29 |
| 295423 | 1784738252 | K211987 | ATEC Alignment App | LLZ | 2021-10-29 |
| 295423 | 1809480714 | K211873 | PSX Interbody System | MAX | 2021-08-10 |
| 145220 | 1809480714 | K211873 | PSX Interbody System | MAX | 2021-08-10 |
| 295423 | 1200038519 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | MAX | 2021-09-22 |
| 145220 | 1200038519 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | MAX | 2021-09-22 |
| 145220 | 1934513346 | K203742 | IdentiTi ALIF Standalone Interbody System | OVD | 2021-04-09 |
| 295423 | 1934513346 | K203742 | IdentiTi ALIF Standalone Interbody System | OVD | 2021-04-09 |
| 295423 | 1776434056 | K203125 | Invictus OCT Spinal Fixation System | NKG | 2020-12-18 |
| 145220 | 1776434056 | K203125 | Invictus OCT Spinal Fixation System | NKG | 2020-12-18 |
| 145220 | 1714386935 | K203056 | Invictus Spinal Fixation System | NKB | 2020-11-23 |
| 295423 | 1714386935 | K203056 | Invictus Spinal Fixation System | NKB | 2020-11-23 |
| 295423 | 1008946892 | K202812 | IdentiTi Cervical Standalone Interbody System | OVE | 2020-12-18 |
| 145220 | 1008946892 | K202812 | IdentiTi Cervical Standalone Interbody System | OVE | 2020-12-18 |
| 295423 | 1790207814 | K202587 | ATEC Lateral Interbody System | MAX | 2020-11-06 |
| 145220 | 1790207814 | K202587 | ATEC Lateral Interbody System | MAX | 2020-11-06 |
| 295423 | 1221499417 | K202327 | Invictus OsseoScrew® System | NKB | 2020-10-15 |
| 145220 | 1221499417 | K202327 | Invictus OsseoScrew® System | NKB | 2020-10-15 |
| 317303 | 1429371642 | K202184 | Practical Navigation Surgical Guidance System (PNSGS) | OLO | 2021-02-24 |
| 295423 | 1429371642 | K202184 | Practical Navigation Surgical Guidance System (PNSGS) | OLO | 2021-02-24 |
| 145220 | 1429371642 | K202184 | Practical Navigation Surgical Guidance System (PNSGS) | OLO | 2021-02-24 |
| 295423 | 1568262095 | K200995 | Insignia Anterior Cervical Plate System | KWQ | 2020-05-21 |
| 145220 | 1568262095 | K200995 | Insignia Anterior Cervical Plate System | KWQ | 2020-05-21 |
| 145220 | 1630095796 | K200936 | Invictus CT Spinal Fixation System | NKG | 2020-05-22 |
| 295423 | 1630095796 | K200936 | Invictus CT Spinal Fixation System | NKG | 2020-05-22 |
| 145220 | 2000772887 | K192938 | Invictus Spinal Fixation System | NKB | 2019-12-12 |
| 295423 | 2000772887 | K192938 | Invictus Spinal Fixation System | NKB | 2019-12-12 |
| 295423 | 1656067592 | K191723 | ATEC IOM Accessory Instruments | PDQ | 2019-10-18 |
| 145220 | 1656067592 | K191723 | ATEC IOM Accessory Instruments | PDQ | 2019-10-18 |
| 295423 | 1323922943 | K191311 | ATEC Lateral Interbody System | MAX | 2019-08-12 |
| 145220 | 1323922943 | K191311 | ATEC Lateral Interbody System | MAX | 2019-08-12 |
| 145220 | 1829734465 | K191185 | Solanas® Posterior OCT Fixation System | NKG | 2019-06-03 |
| 295423 | 1829734465 | K191185 | Solanas® Posterior OCT Fixation System | NKG | 2019-06-03 |
| 145220 | 1505992167 | K183705 | IdentiTi Porous Ti Interbody System | MAX | 2019-03-01 |
| 295423 | 1505992167 | K183705 | IdentiTi Porous Ti Interbody System | MAX | 2019-03-01 |
| 145220 | 1102652023 | K182808 | Aspida® Anterior Lumbar Plating System | KWQ | 2018-11-09 |
| 295423 | 1102652023 | K182808 | Aspida® Anterior Lumbar Plating System | KWQ | 2018-11-09 |
| 145220 | 1657541724 | K182542 | The EPAD 2 System | GWF | 2019-02-22 |
| 295423 | 1657541724 | K182542 | The EPAD 2 System | GWF | 2019-02-22 |
| 145220 | 1079482068 | K181980 | OsseoScrew System | NKB | 2018-09-25 |
| 295423 | 1079482068 | K181980 | OsseoScrew System | NKB | 2018-09-25 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NKB | 44 | 2024-06-21 |
| MAX | 32 | 2025-02-03 |
| OLO | 25 | 2026-02-19 |
| KWQ | 16 | 2025-08-28 |
| KWP | 13 | 2011-06-02 |
| MNI | 10 | 2011-02-08 |
| GWF | 8 | 2026-01-11 |
| OVD | 8 | 2025-09-03 |
| MQP | 8 | 2023-10-06 |
| ODP | 7 | 2025-07-03 |
| MNH | 7 | 2009-04-29 |
| NKG | 6 | 2020-12-18 |
| PDQ | 4 | 2022-09-23 |
| OVE | 4 | 2020-12-18 |
| KCT | 3 | 2012-05-04 |
| OWI | 2 | 2026-03-25 |
| OWB | 2 | 2024-05-22 |
| PML | 2 | 2022-12-20 |
| LLZ | 2 | 2021-10-29 |
| PHM | 2 | 2016-09-08 |
| MRW | 2 | 2012-11-28 |
| JDK | 1 | 2005-10-05 |
PMA
PMN
ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Identi
Alphatec Spine, Inc.
Invictus® Spinal Fixation System
Alphatec Spine, Inc.
SafeOp 2: Neural Informatix System
Alphatec Spine, Inc.
Insignia™ Anterior Cervical Plate System
Alphatec Spine, Inc.
Invictus Spinal Fixation System
Alphatec Spine, Inc.
ATEC Alignment App
Alphatec Spine, Inc.
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
Alphatec Spine, Inc.
PSX Interbody System
Alphatec Spine, Inc.
IdentiTi Cervical Standalone Interbody System
Alphatec Spine, Inc.
Invictus™ OCT Spinal Fixation System
Alphatec Spine, Inc.
Invictus™ Spinal Fixation System
Alphatec Spine, Inc.
ATEC Lateral Interbody System
Alphatec Spine, Inc.
Invictus™ OsseoScrew® System
Alphatec Spine, Inc.
Invictus™ CT Spinal Fixation System
Alphatec Spine, Inc.
Insignia™ Anterior Cervical Plate System
Alphatec Spine, Inc.
Invictus™ Spinal Fixation System
Alphatec Spine, Inc.
ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
ATEC Lateral Interbody System
Alphatec Spine, Inc.
Applications
GUDID
SafeOp 3
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.
Valence Robotic Navigation System
ALPHATEC SPINE, INC.