K2M, INC.

FDA Device Registration & Listing · Leesburg, VA, US · Registration 3004774118

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004774118
FEI Number
3008599177
Entity Name
K2M, INC.
City/State/Country
Leesburg, VA, US
Establishment Address
600 Hope Pkwy SE, Leesburg, VA 20175, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

RONGEUR General Instruments MESA SPINAL SYSTEM Mojave Range, Ari Pyrenees AWL General Instruments NILE CoCr Wire MANUAL DRILL BIT General Instruments DRILL BIT General Instruments Caliper General Instruments Depth Gauge Capri CASPIAN SPINAL SYSTEM Range (Mesa, Denali) Everest Vulcan Spinal System Ozark ALEUTIAN IBF SYSTEM Range, Denali, Mesa Pyrenees Chesapeake Cervical Cayman Caspian OCT/Mesa mini/Denali mini Pyrenees PALO ALTO Corpectomy Cage System PYRENEES SPINAL SYSTEM Pyrenees, Blue Ridge XIA 3 Yukon OCT Spinal System Napa Access System PROBE Vulcan Spinal System General Instruments WIRE (ALL) COMPRESSOR COMPACTOR/COMPRESSION Q Interbody Instruments General Instruments Extractor Cascadia Nile Aleutian Fenestrated Tap System Pyrenees 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 Rhine SAHARA Stabilization System Caspian Spinal System RANGE SPINAL SYSTEM, SMALL STATURE Capri Yukon CASPIAN SPINAL SYSTEM K2M Navigation Instruments Range Spinal System; with pediatric indications General Instruments Impactor, Orthopedic Manual Surgical Instrument RANGE SPINAL SYSTEM, SMALL STATURE Cascadia ALEUTIAN SPACER SYSTEM MESA DENALI DEFORMITY SYSTEM KNIFE Cascadia Interbody System ALEUTIAN AN SPACER SYSTEM RANGE SPINAL SYSTEM Everest, Range, Mesa, Denali Everest Spinal System Everest 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 Everest Spinal System Caspian OCT Spinal System Navigated Spine Instruments PYRENEES CERVICAL PLATE SYSTEM Pyrenees SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System Everest Caspian Sahara RANGE SPINAL SYSTEM General Instruments Bender Caspian, Mesa mini, Denali mini Brainlab Aleutian IBF System RANGE SPINAL SYSTEM RANGE SPINAL SYSTEM (MESA AND DENALI) K2M Patient Specific Rods General Instruments Pyrenees Everest Spinal System Pyrenees Chesapeake Spinal System EVEREST SPINAL SYSTEM Range Spinal System NATURAL BRIDGE EVEREST SPINAL SYSTEM Chesapeake RANGE SPINAL SYSTEM (MESA AND DENALI) Everest ALEUTIAN CAYMAN SPINAL SYSTEM Chesapeake Spinal System K2M Navigation Instruments Rigid Rail DRILL GUIDE Range, Small Stature, Mesa Range Mesa Denali EVEREST Spinal System CAPRI Corpectomy Cage System ALEUTIAN SYSTEM YUKON OCT Spinal System Trays OZARK Cervical Plate System Trays DENALI Spinal System Trays Navigated Spine Instruments Trays CASPIAN Spinal System Trays MESA Spinal System Trays CAYMAN Plate System Trays Q Interbody Instruments Cascadia Interbody System PYRENEES Cervical Plate System Trays ALEUTIAN Interbody Systems Trays SAHARA Stabilization System Trays RAVINE Access System Trays EVEREST Spinal System Trays CHESAPEAKE Stabilization System Trays CAPRI Corpectomy Cage System Trays NAPA Access System Vulcan Spinal System CANYON Retractor Systems Trays Napa Access System K2M Mesa Modular Hooks ALEUTIAN SPACER SYSTEM XIA Rod Template Vikos Allograft System Xia Blocker Inserter K2M General Instruments Vulcan Spinal System Everest Spinal System CASPIAN SPINAL SYSTEM Aleutian Spacer System Chesapeake Lumbar Vulcan Spinal System RANGE SPINAL SYSTEM Cascadia Interbody System Range/Mesa.Denali Spinal System CAYMAN SPINAL SYSTEM Mojave Caspian OCT, Mesa Mini, Denali Mini DENALI CAYMAN BUTTRESS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTX Rongeur Orthopedic Class 1 888.4540 2025-06-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-06-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-06-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
HWJ Awl Orthopedic Class 1 888.4540 2025-04-25
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-04-14
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-04-25
KTZ Caliper Orthopedic Class 1 888.4150 2025-04-25
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-04-25
MQP Spinal Vertebral Body Replacement Device 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 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-04-14
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-04-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-04-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-29
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 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 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
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
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
HXB Probe Orthopedic Class 1 888.4540 2025-04-25
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2025-04-25
HWN Instrument, Compression Orthopedic Class 1 888.4540 2025-04-25
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-11
HWB Extractor Orthopedic Class 1 888.4540 2025-04-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-04-14
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-04-29
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2025-04-25
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
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
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 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 2025-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 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
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-14
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
HWA Impactor Orthopedic Class 1 888.4540 2025-04-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
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
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
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2025-04-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-06-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 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
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
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 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
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
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
HXW Bender Orthopedic Class 1 888.4540 2025-04-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
HXC Wrench Orthopedic Class 1 888.4540 2025-04-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-29
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
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 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 2025-04-14
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-04-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-04-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-14
PWG Spinal Fixation System Unknown Class N N/A 2025-04-29
HXY Brace, Drill Orthopedic Class 1 888.4540 2025-04-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation 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
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
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
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-04-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-06-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-06-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-06-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-06-20
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-06-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-06-20
HWT Template Orthopedic Class 1 888.4800 2025-04-25
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2026-02-18
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-04-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-04-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-02-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-04-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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 2025-04-14
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
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-14
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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-11

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
3004024955 STRYKER SPINE ALLENDALE, NJ, US
9617544 STRYKER SPINE CESTAS Nouvelle-Aquitaine, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04

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
3043008835 STARK SURGICAL INSTRUMENTS Moorpark, CA, US
3006128100 Nemcomed FW LLC FORT WAYNE, IN, US
1226544 MILLSTONE MEDICAL OUTSOURCING LLC. FALL RIVER, MA, US
3011577940 Titan Spine, a Division of Medtronic Milwaukee, WI, US
3007648354 FETZER MEDICAL GMBH & CO.KG Tuttlingen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004774118. Last updated year: 2026. Please use registration number 3004774118 when referencing this establishment in official correspondence.
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