FDA Registration
Active
🇺🇸 United States
ALPHATEC SPINE, INC.
Reg #: 2027467
·
FEI: 2027467
·
Expires 2026
Products
74
Proprietary Names
171
Establishment Types
5
Classifications
74
Registration Details
- Registration Name
- ALPHATEC SPINE, INC.
- Registration Number
- 2027467
- FEI Number
- 2027467
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1950 Camino Vida Roble
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203056
Owner / Operator
- Firm Name
- ALPHATEC HOLDINGS, INC.
- Operator Number
- 9072657
- Address
- 1950 Camino Vida Roble
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Brian - Beireis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-01-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-01-05 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2009-12-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-01-07 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-10-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-10-31 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-10-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2009-12-18 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-04-29 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2023-10-16 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2023-10-16 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2009-06-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2020-07-09 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-06-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-08-09 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-08-09 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-08-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-11-23 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-11-23 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2021-11-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1999-07-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-10-31 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2009-12-18 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-05-06 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2024-05-06 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2024-05-06 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-05-06 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2024-05-06 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2024-05-06 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2005-04-21 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-01-08 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2009-12-18 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 1999-07-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1999-07-20 |
| Bender | HXW | Class 1 | Orthopedic | No | 2009-12-18 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2023-12-01 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2023-02-01 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2009-12-18 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2009-12-18 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2012-11-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2009-06-24 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-12-07 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2020-03-10 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2020-04-10 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2018-10-03 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-17 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-03-26 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2025-02-11 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2004-01-27 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2001-09-24 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1999-07-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1999-07-20 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-05-12 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2019-03-13 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2012-12-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2001-09-24 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-01-27 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2009-12-18 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-09-28 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2005-04-21 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2009-12-18 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2020-03-12 |
| Template | HWT | Class 1 | Orthopedic | No | 1999-07-20 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2005-04-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1999-07-20 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2004-01-27 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2021-06-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2009-12-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2009-12-18 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2020-03-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2009-12-18 |
| Table, Operating-Room, Pneumatic | FWW | Class 1 | General, Plastic Surgery | No | 2025-02-11 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2009-12-18 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2009-12-18 |
Proprietary Names
Invictus
Awl
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
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
ROC
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)
Battalion Lumbar Spacer System
Battalion Universal Spacer System
AlphaInformatix
SafeOp
EPAD2
Aspida Anterior Lumbar Plating System
Invictus OsseoScrew System
Forceps
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 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
Osteotome
Orthopedic Manual Surgical Instrument
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
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
Arsenal Spinal Fixation System
Arsenal CBx
Power Adaptor
Novel Cervical Interbody Spinal Spacer System
Novel CIS/XS Interbody Spinal Spacer System(s)
Calibrate NanoTec CCX Interbody System
ATEC A.R.M.
VEA
Mallet
Novel Spinal Spacer System
Arsenal System, Deformity
Reamer
ATEC Porous Ti (PTi) Thoracolumbar Spacer System
Batalion Lumbar Spinal Spacer
Alphatec Navigation Instruments
Illico MIS®
Arsenal®
AMP-LTX System
Xenon Pedicle Screw System
LIF Anti-Migration Plate (AMP)
Transcend 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
IdentiTi NanoTec SPS Interbody System
Leucadia Cross Connectors
ALLEZ SPINE Cross Connectors
LIF Instruments
Solanas® Posterior Stabilization System
Curette
Invictus Small Stature Spinal Fixation System
Kodiak Spinal Fixation System
RASP
IdentiTi II Interbody System
AMP II
Tamp
STARTER, BONE SCREW
IdentiTi ALIF Oblique Interbody System
IdentiTi ALIF Narrow Interbody System
IdentiTi II and Transcend ALIF Standalone Interbody Systems
Pegasus Inserter
Battalion Lumbar Spinal Spacer System
Wrench
Orthopedic Knife
IdentiTi NanoTec Cervical Standalone Interbody System
Template
Surgical Chisel, Manual
ATEC Lateral Navigation Instruments
Guide, Surgical, Instrument
ATEC Posterior Navigated Disc Prep Instruments
Cobb
Elevator
Insignia Anterior Cervical Plate System
Trephine
Illico MIS Posterior Fixation System
Calibrate NanoTec LTX Interbody System
Drill Bit
Bridgepoint Spinous Process Fixation System
Scalpel Handle
Broach
Arsenal Spinal Fixation System, Degenerative
Screwdriver
Caliper
ATEC Lateral Plate System
Bone Tap
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only