FDA Registration
Active
🇺🇸 United States
JATEX, INC.
Reg #: 3010049501
·
FEI: 3010049501
·
Expires 2026
Products
36
Proprietary Names
15
Establishment Types
1
Classifications
36
Registration Details
- Registration Name
- JATEX, INC.
- Registration Number
- 3010049501
- FEI Number
- 3010049501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 551 Shawnee Drive
- City
- Nappanee
- State
- IN
- ZIP
- 46550
- Country
- US
Owner / Operator
- Firm Name
- Jatex, Inc.
- Operator Number
- 10043044
- Address
- 551 Shawnee Drive
- City
- Nappanee
- State
- IN
- Postal Code
- 46550
- Country
- US
- Correspondent
- Devon Hochstetler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2026-01-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-01-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-01-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2024-04-22 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2026-01-12 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2025-01-22 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-01-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-01-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-22 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-01-12 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2026-01-12 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-01-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-01-12 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-01-12 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-01-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-01-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2026-01-12 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2026-01-12 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-01-12 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-22 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-01-12 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2026-01-12 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2019-12-12 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2026-01-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-08-12 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2026-01-12 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2026-01-12 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2026-01-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-31 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-31 |
Proprietary Names
ENDOSKELETON TC
Plate Bender
Autobahn Evo
Plate Inserter
DRIVER, PROSTHESIS
Fixation
fusion
Fusion
AWL
Wire Guide
REAMER
stereotaxic
TEMPLATE
SCREWDRIVER
BENDER
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)