FDA Registration
Active
🇺🇸 United States
STRYKER SPINE
Reg #: 3004024955
·
FEI: 3004024955
·
Expires 2026
Products
36
Proprietary Names
203
Establishment Types
3
Classifications
36
Registration Details
- Registration Name
- STRYKER SPINE
- Registration Number
- 3004024955
- FEI Number
- 3004024955
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 PEARL COURT
- City
- ALLENDALE
- State
- NJ
- ZIP
- 07401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122845
Owner / Operator
- Firm Name
- VB Spine, LLC
- Operator Number
- 10093189
- Address
- 505 Park Avenue, 14th Floor
- City
- New York
- State
- NY
- Postal Code
- 10022
- Country
- US
- Correspondent
- Christopher Tortora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-04-18 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-04-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-04-18 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-04-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2025-04-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-04-18 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-04-18 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-04-25 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-04-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-04-18 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-09-11 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-04-17 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2025-04-18 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2025-04-17 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-04-29 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-04-24 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2025-07-16 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-07-16 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2025-06-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-04-25 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2025-04-29 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2025-04-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-04-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-04-29 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-04-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-04-24 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-04-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-04-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-06-20 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-08-19 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-08-19 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-04-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-04-25 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-04-18 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-04-24 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2025-04-17 |
Proprietary Names
ES2 Spinal System
Oasys
Y-Wire2 Y-Wire Guidewire
OASYS Saddle Connector
Radius Spinal System Line Ext.
AVS PL - UNILIF
AVS PL PEEK SPACER SYSTEM
XIA Rod Template
Vikos Allograft System
Xia Blocker Inserter
K2M General Instruments
AVS ASL PEEK Spacers
BLUE RIDGE Cervical Plate System
OZARK Cervical Plate System
PYRENEES Cervical Plate System
CAYMAN Thoracolumbar and Buttress Plate system
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Tritanium® X PL Expandable Posterior Lumbar Cage
Reflex Hybrid ACP System
OASYS
Anchor-L
Vitoss BA Bioactive Bone Graft Substitute
Xia 4.5 Spinal System
Escalate Laminoplasty self-drilling screws
Escalate Laminoplasty self-tapping screws
Escalate Laminoplasty Base (hinge) plate
Escalate Laminoplasty Expandable plate
SAHARA Stabilization System
AVS Navigator PEEK Spacers
Xia Spinal System
Tritanium PL Cage
Aero-AL
AccuLIF
AVS ARIA
AVS Anchor-L
AVS AL
AVS TL
AVS PL
AVS UniLIF
AVS Navigator
AVS ALign
LITe Decompression
AccuLIF TL and PL Cages
AccuLIF TL and PL Cages associated instrumentation
Oasys System
Xia 4.5 Spinal System - Line Ext.
XIA 4.5 XIA CT (Corticol Trajectory)
Opus Spinal System
Nile® Proximal Fixation Spinal System
XIA® II Spinal System
Serrato® Spinal System
Trio® & Trio+ Spinal Fixation System
ES2 Augmentable Spinal System
Radius® Spinal System
ES2 Spinal System
Oasys® Occipito-Cervico-Thoracic System
XIA® Anterior
Mantis® Spinal System
Nile® Alternative Fixation Spinal System
XIA® 3 Spinal System
XIA® Precision System
Escalate® Laminoplasty System
XIA® 4.5 Cortical Trajectory
XIA® Growth Rod Conversion Set
Mantis® Redux
XIA® 4.5 Spinal System
Diapason® Spinal System
AVS TL PEEK Spacers
RAYLOR ELEVATOR
Retractor
SURGICAL KNIVES
CHISELS
DISSECTORS
FORCEPS
OSTEOTOMES
FASCIA CUTTER
BLADES, PROBES
Xia® 3 Spinal System - Serrato
Stryker Spine Power Adaptor Accessory
STRYKER TUNNELER STRYKER Y-NEEDLE 100 STRYKER Y-NEEDLE 200 STRYKER Y-NEEDLE 300 STRYKER Y-NEEDLE 400
ES2 Neuromonitoring Accessory Instruments
LITe BIO Delivery System - Delivery Handle
LITe BIO Delivery System - Sterile Package with Cannula
LITe BIO Delivery System - Delivery Plunger
Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip
VITOSS BONE GRAFT SUBSTITUTE
XIA 3
Yukon OCT Spinal System
Napa Access System
Radius Vitallium Rod
Radius Spinal System
VLIFT Vertebral Body Replacement
BWM Spine System
XIA SPINAL SYSTEM
Imbibe Needle
DRILL GUIDE
Nulock
VITOSS BA2X BIOACTIVE BONE GRAFT SUBSTITUTE
AVS® ARIA PEEK Spacer
AVS® AL
AVS® Navigator PEEK Spacer
AVS® UniLIF PEEK Spacers
AVS® TL PEEK Spacer
AVS ® PL
AVS® ALign PEEK Spacers
Tritanium TL Curved Posterior Lumbar Cage
Xia 3
XIA TI AND SS SPINAL SYSTEMS
XIA VITALLIUM, MULTIPLE
Xia 4.5
Aero-LL
UniVise Spinous Process Fixation Plate Spinous Process Fixation Plate
Reflex Hybrid Anterior Cervical Plate System
LITe® Plate System Appliance, fixation, spinal intervertebral body
Aviator® Anterior Cervical Plate System
DynaTran Anterior Cervical Plate System
Spinal Interlaminal Fixation Orthosis-Oasys Transition Rods
Stryker Spine AVS AS PEEK Spacers
Aleutian IBF System
Aero-LL Lumbar Cage System
Tritanium® PL Cage
Aero-AL Lumbar Cage System
Monterey AL Interbody System
Mojave Expandable Interbody System
AVS® Anchor-L Spacer
Ascential IBD PEEKc Spacer
AVS® UniLIF PEEK Spacer
Aero®-C Cervical Cage System
Stryker Spine VLIFT Vertebral Body Replacement System
AVS® PL PEEK Spacer
Tritanium® TL Curved Posterior Lumbar Cage
Capri Corpectomy Cage System
VLIFT®-s Vertebral Body Replacement System
AVS® Aria PEEK Spacer
Chesapeake Stabilization System
AVS® Anchor-C Cervical Cage System
Cascadia Interbody System
Tritanium® C Anterior Cervical Cage
AVS® AL PEEK Spacer
AVS® AS PEEK Spacer
Santorini Corpectomy Cage System
Sahara Stabilization System
Tritanium C Anterior Cervical Cage
AVS PL PEEK Spacers
OPUS BONE SCREWS MULTIPLE SIZES
LITe BIO Delivery System - Loading Funnel
LITe BIO Delivery System - Loading Tool
OSS ROD UNION
SPINE OSS DOMINO CONNECTOR
SPINE OSS RODS, BONE SCREWS
XIA 4.5 Spinal System
Reflex Zero Profile ACP System
AVS Anchor-C Cervical Cage
AVS AS
Mantis Spinal System
Mantis Redux System
Xia
AVS ARIA PEEK Spacers
Vitoss BiModal Bioactive Bone Graft Substitute
Vitoss BBTrauma Bioactive Bone Graft Substitute
XIA 3 Uniplanar & Reduction Screws
Multi-Axial Cross (MAC) Connectors
Vitoss Bioactive Foam Strip
AVIATOR
IMBIBE BONE MARROW ASPIRATION SYRINGE
TRIO+ SPINAL FIXATION SYSTEM
TRIO SPINAL FIXATION SYSTEM
TRIO TRAUMA SPINAL
MANTIS REDUX SPINAL SYSTEM
RADIUS SPINAL SYSTEM
MANTIS
Xia 3 Spinal System
AVS UniLIF PEEK Spacers
XIA Ti LONG ARM POLYAXIAL SCREWS
XIA Ti LONG ARM MONOAXIAL SCREWS
XIA Ti LONG ARM PEDICLE HOOK, SMALL
XIA Ti LONG ARM LAM. HOOKS, MULTIPL
AERO-C Cervical Cage System
TRIO TRAUMA SPINAL SYSTEM
XIA 3 Spinal System
OASYS CROSS CONNECTOR PLATE
OASYS CC PLATE BLOCKER
OASYS CC PLATE NUT
XIA Ti AND SS SPINAL SYSTEMS
Stryker Spine Power Adaptor
Vulcan Spinal System
Q Interbody Instruments
ORTHOPEDIC MANUAL
UniVise
Orthopaedic Manual Instrumentation
General Instruments
Terra Nova, Ravine, Serengeti, VCR, Cricket
Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest
Screw Insertion Sleeve
NAPA Access System
Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini
Drill Bit
Vitoss Foam Bone Graft Substitute
Navigation Enabled (Xia 2, Xia 3, Xia 4.5, ES2, Mantis)
Stryker KWIC Needle
VITOMATRIX BONE GRAFTING MATERIAL
Monterey AL Interbody System
AVS ASL PEEK Spacer System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility