Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019878714

FEI Number

3019878714

Entity Name

Alphatec Spine, Inc.

City/State/Country

Memphis, TN, US

Establishment Address

4101 Willow Lake Blvd., Memphis, TN 38118, 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

K232275

PMA Number

N/A

All Registered Proprietary Names

Orthopedic Manual Surgical Instrument Arsenal Spinal Fixation System Arsenal CBx Mallet VEA Sterilization Container used with Remi Robotic Navigation System IdentiTi NanoTec Interbody System IdentiTi Cervical Standalone Interbody System Transcend NanoTec Interbody System IdentiTi NanoTec ALIF Standalone Interbody System IdentiTi ALIF Standalone Interbody System IdentiTi Porous Ti Interbody System IdentiTi NanoTec Cervical Standalone Interbody System Transcend PEEK Interbody System Zodiac Lumbar Spinal Fixation System Alphatec Spine Posterior Cervico-Thoracic Spinal Fixation System Avalon Occipital Plate Solanas Posterior Cervico-Thoracic Spinal Fixation System Invictus Calibrate NanoTec PSX Interbody System Calibrate PSX Interbody System Solanas IdentiTi Porous Ti Interbody System ATEC Porous Ti (PTi) Thoracolumbar Spacer System Batalion Lumbar Spinal Spacer Solanas® Posterior Stabilization System 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 Invictus IdentiTi Leucadia Cross Connectors ALLEZ SPINE Cross Connectors Zodiac Lumbar Spinal Fixation System Battalion Lumbar Spacer System Battalion Universal Spacer System Cobb Elevator PSX Calibrate PSX Insignia Anterior Cervical Plate System Orthopedic Knife Drill Bit Curette Kodiak Spinal Fixation System Invictus Spinal Fixation System Guide, Surgical, Instrument Targeting Needle Disposable Aspiration and Injection Needle Solanas Surgical Dissector, General & Plastic Surgery Bone Tap Illico FS Facet Fixation System Transcend NanoTec SPS Interbody System IdentiTi SPS Interbody System Transcend SPS Interbody System Segmental Plating System (SPS) IdentiTi NanoTec SPS Interbody System ZODIAC Spinal Fixation System Trestle Luxe® II Anterior Cervical Plating System Trestle Luxe® Anterior Cervical Plating System Calibrate PSX Interbody System Calibrate NanoTec CCX Interbody System Calibrate NanoTec PSX Interbody System Calibrate CCX Interbody System Bridgepoint Spinous Process Fixation System Trephine STARTER, BONE SCREW Screwdriver Calibrate LTX Interbody System Calibrate NanoTec LTX Interbody System IdentiTi II Cervical Interbody System Phygen Leucadia Leucadia Pedicle Screw System IdentiTi II and Transcend ALIF Standalone Interbody Systems IdentiTi ATEC Lateral Navigation Instruments Invictus Robotic Navigation Instruments Forceps Power Adaptor Avalon Occipital Fixation System Solanas Posterior OCT Fixation System AlphaInformatix SafeOp EPAD2 Proximity Anterior Cervical Plate System Segmental Plating System (SPS) Bender Invictus Bone Cement, Invictus Spinal Fixation System Zodiac Spinal Fixation System Illico MIS Posterior Spinal Fixation System Pegasus Inserter Zodiac Lumbar Spinal Fixation System Invictus Small Stature Spinal Fixation System Surgical Chisel, Manual Zodiac Lumbar Spinal Fixation System Illico MIS Posterior Spinal Fixation System Invictus Spinal Fixation System Broach Aspida Anterior Lumbar Plating System Invictus OsseoScrew System Reamer Osteotome Remi Robotic Navigation System Illico MIS Posterior Fixation System LIF Instruments IdentiTi and Transcend Interbody Systems Novel Interbody Spinal System (ACC/LCC) Invictus IntraOp Alignment System Illumination System RASP Awl Battalion Lumbar Spacer System Illico MIS IdentiTi II Interbody System AMP II SafeOp 3 System Illico 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 Invictus Zodiac Spinal Fixation System SafeOp EPAD2 AlphaInformatix AMP-LTX System Calibrate LTX Interbody System Core ROC Arsenal Spinal Fixation System Arsenal Spinal Fixation System, Degenerative LIF Anti-Migration Plate (AMP) Transcend Interbody System IdentiTi Porous Ti Interbody System Rongeur Calibrate LTX Interbody System Remi Robotic Navigation System Invictus Probe Novel Cervical Interbody Spinal Spacer System Novel CIS/XS Interbody Spinal Spacer System(s) Novel Spinal Spacer System Cutting Instrument, Orthopedic Impactor Novel Interbody Spinal Spacer System (LCC/SD/XS) Valence Robotic Navigation System Invictus Robotic Navigation Instruments ATEC Posterior Navigated Disc Prep Instruments Wrench OsseoScrew System Invictus Caliper Aspida Anterior Lumbar Plating System Zodiac Lumbar Spinal Fixation System Invictus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1999-07-20
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
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2004-01-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-11-04
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-05-12
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-08-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-08-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-08-15
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2022-08-15
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
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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-02-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-07-18
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
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
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
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
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-03-26
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-01-05
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
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
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
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2004-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-08-25
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-09-09
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2009-12-18
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2009-12-18
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-12-21
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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1999-07-20
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-06-24
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
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-06-24
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2009-12-18
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2012-11-29
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
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-04-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-03-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-11-01
HWK	Trephine	Orthopedic	Class 1	888.4540	2021-06-03
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2009-12-18
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2009-12-18
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-09-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-09-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-09-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-08-01
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-09-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-09-04
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-04-12
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-03-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-11-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-04-21
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-08-17
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
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	2025-09-12
HXW	Bender	Orthopedic	Class 1	888.4540	2009-12-18
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
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
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2015-05-11
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
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
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2005-04-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2007-11-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	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	2022-04-06
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-04-06
HTQ	Broach	Orthopedic	Class 1	888.4540	2020-03-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-01-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-01-19
HTO	Reamer	Orthopedic	Class 1	888.4540	2001-09-24
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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-12
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-12
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-03-13
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
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-11-07
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2021-01-07
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
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2023-12-01
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2001-09-24
HWJ	Awl	Orthopedic	Class 1	888.4540	2009-12-18
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-01-08
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
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
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2020-03-12
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
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
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
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
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
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
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2014-03-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-03-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-03-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-03-25
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
HTX	Rongeur	Orthopedic	Class 1	888.4540	2009-12-18
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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-12
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2020-05-22
HXB	Probe	Orthopedic	Class 1	888.4540	2009-12-18
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	2008-08-27
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-08-27
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1999-07-20
HWA	Impactor	Orthopedic	Class 1	888.4540	1999-07-20
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-11-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-29
HXC	Wrench	Orthopedic	Class 1	888.4540	2005-04-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-01-09
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
KTZ	Caliper	Orthopedic	Class 1	888.4150	2009-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-04-11
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-09-28
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2023-09-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-09-28
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-09-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-28

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
2027467	ALPHATEC SPINE, INC.	Carlsbad, CA, 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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019878714. Last updated year: 2026. Please use registration number 3019878714 when referencing this establishment in official correspondence.