FDA Registration
Active
🇺🇸 United States
J&B PRECISION, INC.
Reg #: 3010041430
·
FEI: 3010041430
·
Expires 2026
Products
37
Proprietary Names
20
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- J&B PRECISION, INC.
- Registration Number
- 3010041430
- FEI Number
- 3010041430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9261 Cordova Park Rd
- City
- Cordova
- State
- TN
- ZIP
- 38018
- Country
- US
Owner / Operator
- Firm Name
- J&B Precision, Inc.
- Operator Number
- 10042782
- Address
- 9261 Cordova Park Road.
- City
- Cordova
- State
- TN
- Postal Code
- 38018
- Country
- US
- Correspondent
- Carl E Buckalew
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-01-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-22 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-22 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-01-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2026-01-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-01-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-01-21 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-06-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-06-12 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2026-01-21 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2016-03-20 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-03-20 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-12-28 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2025-01-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-04-16 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-01-21 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-01-22 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2025-01-22 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-05-04 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2012-12-28 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-01-22 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-01-22 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2015-04-17 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-01-21 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2017-05-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-04 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2025-01-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-12-28 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-01-21 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2025-01-22 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-04-13 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2025-01-21 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2026-01-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-04-13 |
Proprietary Names
PRECONTOURED ROD, 5.5MM
Bone Screw
FUZE INTRAMEDULLARY INTERNAL FIXATION NAIL
Buttress Screw
MONOAXIAL SCREW, 4.5MM
Occipital Screw
Pedicle Marker Pin
CERVICAL VERTEBRAE PLATE
Rod
Precontoured Rod
EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
Temporary Fixation Pin
ROD, 5.5MM
Plate, Fixat ORTHOLOC 3DI HALLUX SYSTEM
BONE PLATE SYSTEM
CANNULATED UNI-PLANAR DLTA SCREW
Plate, Fixat ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCEW
Screw, Fixa DARCO HEADED CANNULATED SCREW
CANNULATED BONE SCREW
CANNULATED BONE SCREW DOUBLE THREAD
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)