TOMZ Corporation

FDA Device Registration & Listing · Berlin, CT, US · Registration 1224360

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
1224360
FEI Number
1000514086
Entity Name
TOMZ Corporation
City/State/Country
Berlin, CT, US
Establishment Address
47 Episcopal Rd, Berlin, CT 06037, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
TOMZ Corporation (Owner Number: 10042199)
Owner / Operator Contact Address
47 Episcopal Road, Berlin, CT 06037, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Invictus Spinal Fixation System SYMPHONY™ OCT System Multiple Products Skeletal Dynamics Invictus Spinal Fixation System Skeletal Dynamics Multiple Products THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Minuteman G5 Skeletal Dynamics

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 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-30
HWT Template Orthopedic Class 1 888.4800 2013-01-11
HXC Wrench Orthopedic Class 1 888.4540 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-30
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-16
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
HXW Bender Orthopedic Class 1 888.4540 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-06
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-13
HWA Impactor Orthopedic Class 1 888.4540 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-11
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-10-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
HWB Extractor Orthopedic Class 1 888.4540 2013-01-11
HTQ Broach Orthopedic Class 1 888.4540 2013-01-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-03-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-03-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
HXX Screwdriver Orthopedic Class 1 888.4540 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-10-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-10-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-10-13
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-12-14
HWJ Awl Orthopedic Class 1 888.4540 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-03-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-03-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-01-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-10-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-10-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-10-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-10-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-10-13
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-10-13
HTF Curette General, Plastic Surgery Class 1 878.4800 2013-01-11
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-06
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KTZ Caliper Orthopedic Class 1 888.4150 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-10-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-10-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-10-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-10-31
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-03-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-03-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-03-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-03-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-13
DZK Wire, Fixation, Intraosseous Dental Class 2 872.4880 2013-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-14
HWX Tap, Bone Orthopedic Class 1 888.4540 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-10

Official Correspondent

Tom Matulaniec

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TOMZ Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1224360. Last updated year: 2026. Please use registration number 1224360 when referencing this establishment in official correspondence.
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