Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004024955

FEI Number

3004024955

Entity Name

STRYKER SPINE

City/State/Country

ALLENDALE, NJ, US

Establishment Address

2 PEARL COURT, ALLENDALE, NJ 07401, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

VB Spine, LLC (Owner Number: 10093189)

Owner / Operator Contact Address

505 Park Avenue, 14th Floor, New York, NY 10022, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162262

PMA Number

N/A

All Registered 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 Xia 4.5 Spinal System Xia 4.5 Spinal 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 Xia 4.5 Spinal System 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) Aero-AL 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 Spinal System 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 Radius Spinal System 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 Reflex Hybrid ACP System XIA VITALLIUM, MULTIPLE Xia 3 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 Tritanium® X PL Expandable Posterior Lumbar Cage Aero®-C Cervical Cage System AVS® TL PEEK Spacer 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® X TL Expandable Curved Posterior Lumbar Cage Tritanium® C Anterior Cervical Cage Napa Access System AVS® Navigator PEEK Spacer 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 AVS PL PEEK Spacers Xia Spinal System LITe BIO Delivery System - Loading Funnel LITe BIO Delivery System - Loading Tool VITOSS BONE GRAFT SUBSTITUTE OSS ROD UNION SPINE OSS DOMINO CONNECTOR SPINE OSS RODS, BONE SCREWS XIA 4.5 Spinal System Reflex Zero Profile ACP System Oasys Radius Spinal System AccuLIF 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 Oasys System Tritanium PL Cage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
HWT	Template	Orthopedic	Class 1	888.4800	2025-04-25
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-08-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-04-18
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-09-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-09-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2025-04-18
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-04-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2025-04-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-24
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-07-16
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2025-07-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-07-16
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2025-07-16
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2025-07-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-07-16
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-07-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-04-18
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-06-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-04-25
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2025-04-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-24
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-04-29
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-04-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-04-24
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-24
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-04-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-04-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-06-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-08-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-08-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-08-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-08-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-08-19
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2025-08-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-08-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-17
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-04-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-09-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-04-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-24
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-09-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24

Official Correspondent

Christopher Tortora

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VB Spine, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004774118	K2M, INC.	Leesburg, VA, US
9617544	STRYKER SPINE	CESTAS Nouvelle-Aquitaine, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number	Establishment Name	Location
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
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3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004024955. Last updated year: 2026. Please use registration number 3004024955 when referencing this establishment in official correspondence.