FDA Registration
Active
🇺🇸 United States
TOMZ Corporation
Reg #: 1224360
·
FEI: 1000514086
·
Expires 2026
Products
34
Proprietary Names
7
Establishment Types
1
Classifications
34
Registration Details
- Registration Name
- TOMZ Corporation
- Registration Number
- 1224360
- FEI Number
- 1000514086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 47 Episcopal Rd
- City
- Berlin
- State
- CT
- ZIP
- 06037
- Country
- US
Owner / Operator
- Firm Name
- TOMZ Corporation
- Operator Number
- 10042199
- Address
- 47 Episcopal Road
- City
- Berlin
- State
- CT
- Postal Code
- 06037
- Country
- US
- Correspondent
- Tom Matulaniec
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-14 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-14 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-11 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-11 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-11 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2026-01-23 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-02-06 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-01-14 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-14 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2013-01-14 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-16 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-01-11 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-01-11 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-14 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-11 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-01-23 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-12-14 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-01-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-11 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-14 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-14 |
| Wire, Fixation, Intraosseous | DZK | Class 2 | Dental | No | 2013-12-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-15 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-11 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-01-14 |
Proprietary Names
Invictus Spinal Fixation System
SYMPHONY OCT System
Multiple Products
Skeletal Dynamics
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Minuteman G5
NuVasive
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)