Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027467

FEI Number

2027467

Entity Name

ALPHATEC SPINE, INC.

City/State/Country

Carlsbad, CA, US

Establishment Address

1950 Camino Vida Roble, Carlsbad, CA 92008, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALPHATEC HOLDINGS, INC. (Owner Number: 9072657)

Owner / Operator Contact Address

1950 Camino Vida Roble, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Invictus Awl Invictus Zodiac Lumbar Spinal Fixation System Calibrate CCX Interbody System Probe Phygen Leucadia Leucadia Pedicle Screw System Ascend VBR System Targeting Needle Disposable Aspiration and Injection Needle Trestle Avalon Solanas Sigma IdentiTi Kodiak AMP Alphagraft Bridgepoint Osseoscrew Illico Invictus Novel Battalion Aspida Xenon Zodiac Arsenal Core Arsenal Cannulated Arsenal Spinal Fixation System, Cannulated IntraOp Alignment System Transcend NanoTec Interbody System IdentiTi NanoTec Interbody System IdentiTi Porous Ti Interbody System Transcend PEEK Interbody System Impactor Insignia Invictus Robotic Navigation Instruments Valence Robotic Navigation System Avalon Occipital Fixation System Solanas Posterior OCT Fixation System Core ROC Invictus Compressor/Distractor Compressor Novel Interbody Spinal System (ACC/LCC) IdentiTi II Cervical Interbody System Zodiac Spinal Fixation System Illico MIS Posterior Spinal Fixation System Remi Robotic Navigation System SafeOp 3 System Proximity Anterior Cervical Plate System Segmental Plating System (SPS) Zodiac Lumbar Spinal Fixation System Battalion Lumbar Spacer System Battalion Universal Spacer System AlphaInformatix SafeOp EPAD2 Aspida Anterior Lumbar Plating System Invictus OsseoScrew System Forceps Zodiac Lumbar Spinal Fixation System IdentiTi Aspida Anterior Lumbar Plating System Battalion Lumbar Spacer System Illico MIS Solus Anterior Lumbar Interbody Fusion (ALIF) System Solus Anterior Lumbar Interbody Fusion Bending Instrument Invictus Spinal Fixation System IdentiTi ALIF Standalone Interbody System IdentiTi Porous Ti Interbody System Transcend PEEK Interbody System Transcend NanoTec Interbody System IdentiTi NanoTec Interbody System IdentiTi NanoTec ALIF Standalone Interbody System PSX Calibrate PSX Novel ALS Interbody Spinal Spacer System Alphatec Spine Posterior Cervico-Thoracic Spinal Fixation System Avalon Occipital Plate Solanas Posterior Cervico-Thoracic Spinal Fixation System SafeOp EPAD2 AlphaInformatix Osteotome Remi Robotic Navigation System Orthopedic Manual Surgical Instrument Zodiac Lumbar Spinal Fixation System Illico MIS Posterior Spinal Fixation System OsseoScrew System Bender Illumination System Invictus Bone Cement, Invictus Spinal Fixation System Rongeur Trestle Luxe® II Anterior Cervical Plating System Trestle Luxe® Anterior Cervical Plating System Gauge Depth Gauge Illico FS Facet Fixation System SafeOp AlphaInfomatix EPAD 2 SafeOp 3: Neural Informatix System Surgical Dissector, General & Plastic Surgery IdentiTi Cervical Porous Ti Interbody System Transcend Cervical PEEK Interbody System IdentiTi Cervical Standalone Interbody System IdentiTi NanoTec Cervical Interbody System Transcend NanoTec Cervical Interbody System IdentiTi NanoTec Cervical Standalone Interbody Sytem DRIVER, PROSTHESIS ZODIAC Spinal Fixation System Novel Interbody Spinal Spacer System (LCC/SD/XS) FORCEPS, WIRE HOLDING Calibrate LTX Interbody System IdentiTi and Transcend Interbody Systems Calibrate NanoTec PSX Interbody System Calibrate PSX Interbody System SafeOp Arsenal Spinal Fixation System Arsenal CBx Solanas Power Adaptor Novel Cervical Interbody Spinal Spacer System Novel CIS/XS Interbody Spinal Spacer System(s) Calibrate PSX Interbody System Calibrate NanoTec CCX Interbody System Calibrate NanoTec PSX Interbody System Calibrate CCX Interbody System Invictus ATEC A.R.M. VEA Solanas Mallet Zodiac Lumbar Spinal Fixation System Novel Spinal Spacer System Remi Robotic Navigation System Arsenal System, Deformity Arsenal Spinal Fixation System Reamer IdentiTi Porous Ti Interbody System ATEC Porous Ti (PTi) Thoracolumbar Spacer System Batalion Lumbar Spinal Spacer Alphatec Navigation Instruments Illico MIS® Arsenal® Invictus AMP-LTX System Calibrate LTX Interbody System Xenon Pedicle Screw System Zodiac Lumbar Spinal Fixation System LIF Anti-Migration Plate (AMP) Transcend Interbody System IdentiTi Porous Ti Interbody System Cutting Instrument, Orthopedic Retractor Sterilization Container used with Remi Robotic Navigation System Transcend NanoTec SPS Interbody System IdentiTi SPS Interbody System Transcend SPS Interbody System Segmental Plating System (SPS) IdentiTi NanoTec SPS Interbody System Leucadia Cross Connectors ALLEZ SPINE Cross Connectors Invictus LIF Instruments Invictus Solanas® Posterior Stabilization System Curette Invictus Small Stature Spinal Fixation System Kodiak Spinal Fixation System Invictus Spinal Fixation System RASP IdentiTi II Interbody System AMP II Tamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-01-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-01-05
HWJ	Awl	Orthopedic	Class 1	888.4540	2009-12-18
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2021-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2008-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-10-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-10-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-10-16
HXB	Probe	Orthopedic	Class 1	888.4540	2009-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-04-29
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-10-16
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2023-10-16
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-06-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-07-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-06-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-06-16
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-06-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-06-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-06-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-08-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-08-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-08-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-11-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-11-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-11-23
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2021-11-23
HWA	Impactor	Orthopedic	Class 1	888.4540	1999-07-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-12-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-04-21
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2020-04-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2009-06-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2009-06-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2009-06-24
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2020-05-22
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2009-12-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-11-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-08-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-04-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2024-05-06
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-05-06
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2024-05-06
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2024-05-06
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2024-05-06
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2024-05-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-09-12
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-11-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-11-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-11-01
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2016-11-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-11-07
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2019-10-29
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2019-10-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-04-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-01-19
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-04-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-10-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-10-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2008-10-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-04-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-01-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-01-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-03-27
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2009-12-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-04-06
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-04-06
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2023-06-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-06-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-06-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-08-25
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2009-06-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2009-06-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2011-07-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-07-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-07-25
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2022-10-06
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-10-06
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1999-07-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1999-07-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-11-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2007-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2007-11-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-01-09
HXW	Bender	Orthopedic	Class 1	888.4540	2009-12-18
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2023-12-01
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2023-02-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-02-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-02-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-02-01
HTX	Rongeur	Orthopedic	Class 1	888.4540	2009-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-04-11
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2009-12-18
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2012-11-29
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2019-02-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-02-22
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2019-02-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2019-02-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2019-02-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2019-02-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-02-19
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-06-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-12-07
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2022-12-07
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2020-03-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-11-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-11-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2007-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2007-11-07
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-11-07
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2020-04-10
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-12-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-12-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-02-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-24
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-02-24
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-02-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-07-18
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-10-03
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-05-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-05-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-05-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-05-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-05-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-05-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-05-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-08-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2008-10-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-03-05
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-03-26
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2025-02-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-11-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2007-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2007-11-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2007-11-07
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2004-01-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-04-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2008-08-27
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-08-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-26
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-01-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-01-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-01-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-01-26
HTO	Reamer	Orthopedic	Class 1	888.4540	2001-09-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-03-01
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-03-01
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2019-03-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-03-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-05-03
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2023-03-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-30
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-03-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-03-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-03-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-03-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-04-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-11-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-11-12
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-11-12
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1999-07-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1999-07-20
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-05-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-05-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-05-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-04-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-02-14
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-03-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-12-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-12-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-30
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-12-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-06-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-01-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-01-09
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2001-09-24
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-10-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-10-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-10-17
HXG	Tamp	Orthopedic	Class 1	888.4540	2004-01-27

Official Correspondent

Brian Beireis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALPHATEC HOLDINGS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015537048	ALPHATEC SPINE, INC.	Louisville, CO, US
3019878714	Alphatec Spine, Inc.	Memphis, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027467. Last updated year: 2026. Please use registration number 2027467 when referencing this establishment in official correspondence.