FDA Registration
Active
🇺🇸 United States
B & J Medical LLC
Reg #: 3009973699
·
FEI: 3009973699
·
Expires 2026
Products
43
Proprietary Names
19
Establishment Types
1
Classifications
43
Registration Details
- Registration Name
- B & J Medical LLC
- Registration Number
- 3009973699
- FEI Number
- 3009973699
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4268 East US Hwy 6
- City
- Kendallville
- State
- IN
- ZIP
- 46755
- Country
- US
Owner / Operator
- Firm Name
- B&J Medical
- Operator Number
- 10042587
- Address
- 4268 East U.S. Hwy 6
- City
- Kendallville
- State
- IN
- Postal Code
- 46755
- Country
- US
- Correspondent
- Michael Winkelman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-06-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-06-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-11-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-06-18 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-06-18 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-09-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-11-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-11-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-11-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-11-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-06-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-07-25 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2016-08-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2021-01-28 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2021-01-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-11-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-01-13 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2024-06-24 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-09-11 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-09-11 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-02-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-11-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2020-11-25 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2021-01-29 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-01-13 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2025-09-23 |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | Class 1 | General, Plastic Surgery | No | 2019-09-23 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2023-01-13 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-06-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-06-14 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-04-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-11-25 |
| Venous Window Needle Guide | PFH | Class 2 | Gastroenterology, Urology | No | 2015-08-27 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-02-02 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2015-01-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-06-18 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-05-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-05-04 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2023-08-01 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-11-20 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2020-11-25 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2012-12-11 |
Proprietary Names
LOCKING PROXIMAL FERMUR PLATE
RESPONSE SPINAL SYSTEM
AO 4MM CANNULATED DRILL
PediPlates
Band-Loc
PEDLIOC
Delta Plates
RESPONSE Spine System
Orthopedicatrics
Cannulated Bone Screws
Orthopediactrics
B&J Medical
Response 5.5/6 Spine System
Locking Cannulated Blade Plate System
Vital Access Corp.
PediLoc Fragment System
I-HIP
PediNail
4.5 mm Cannulated Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)