Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617544

FEI Number

3003112432

Entity Name

STRYKER SPINE

City/State/Country

CESTAS Nouvelle-Aquitaine, FR

Establishment Address

ZONE INDUSTRIELLE DE MARTICOT, CESTAS Nouvelle-Aquitaine 33610, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

OASYS RAYLOR ELEVATOR Mantis Redux System YUKON OCT Spinal System OPUS BONE SCREWS MULTIPLE SIZES Radius Spinal System Line Ext. AVS® ARIA PEEK Spacer AVS® AL AVS® Navigator PEEK Spacer AVS® UniLIF PEEK Spacers AVS® TL PEEK Spacer AVS ® PL AVS® ALign PEEK Spacers BWM Spine System XIA SPINAL SYSTEM Tritanium PL Cage DENALI DEFORMITY SYSTEM Mantis Spinal System XIA 3 Spinal System AVS PL - UNILIF AVS PL PEEK SPACER SYSTEM Radius Spinal System Xia 3 Xia 4.5 Xia 4.5 Spinal System Xia Spinal System OSS ROD UNION SPINE OSS DOMINO CONNECTOR SPINE OSS RODS, BONE SCREWS AERO-C Cervical Cage System Xia XIA VITALLIUM, MULTIPLE EVEREST SPINAL SYSTEM Everest Ozark AVS Navigator PEEK Spacers Multi-Axial Cross (MAC) Connectors Xia Stainless Steel Spinal System Xia Titanium Spinal System Ascential IBD PEEKc Spacer Oasys Monterey AL Interbody System XIA Ti AND SS SPINAL SYSTEMS Radius Vitallium Rod Radius Spinal System XIA 4.5 XIA CT (Corticol Trajectory) Radius Spinal System AVIATOR Tritanium PL Cage MESA Vulcan Spinal System General Instruments Screwdriver Xia Spinal System Xia Spinal System XIA TI AND SS SPINAL SYSTEMS Aero-LL ES2 Neuromonitoring Accessory Instruments Range/Mesa/Denali Stryker Spine Power Adaptor Nulock OASYS Saddle Connector AVS AS Spinal Interlaminal Fixation Orthosis-Oasys Transition Rods AVS TL PEEK Spacers DENALI Xia® 3 Spinal System - Serrato Stryker Spine Power Adaptor Accessory Cascadia Interbody System 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 SURGICAL KNIVES CHISELS DISSECTORS FORCEPS OSTEOTOMES FASCIA CUTTER BLADES, PROBES XIA 4.5 Spinal System Xia 3 Spinal System AVS ASL PEEK Spacers Xia 4.5 Spinal System LITe BIO Delivery System - Loading Funnel LITe BIO Delivery System - Loading Tool Range/Mesa/Denali Spinal System ES2 Spinal System AVS PL PEEK Spacers Xia 3 Tritanium PL Cage Tritanium TL Curved Posterior Lumbar Cage General Instruments Depth Gauge Range Spinal System; with pediatric indications Xia 4.5 Spinal System Range, Mesa, Denali, Natural Bridge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-06-20
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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-04-14
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	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	2025-04-24
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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-11
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
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
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	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
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	2025-04-18
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
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
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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
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
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-24
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	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
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-14
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-14
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	2025-04-24
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
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
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-24
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
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	2025-04-24
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
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
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
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
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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-11
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-04-25
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
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
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
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
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
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-04-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-14
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
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	2025-04-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-04-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-11
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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-04-29
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
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
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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	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
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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-04-25
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-04-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-04-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
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
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	2025-04-18
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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
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
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2025-04-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-04-14
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	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	2025-04-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Justin Eggleton Business: VB Spine, LLC Email: justin.eggleton@vbspineco.com Phone: (571) 2762137

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VB Spine, LLC

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004774118	K2M, INC.	Leesburg, VA, US
3004024955	STRYKER SPINE	ALLENDALE, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K161478	Xenco Medical, LLC	Xenco Medical Posterior Cervical System	2016-09-06
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
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 9617544. Last updated year: 2026. Please use registration number 9617544 when referencing this establishment in official correspondence.