Contract manufacturerB & J Medical LLC (Kendallville, IN)IndianaGeneral and plastic surgeryOrthopedicNeurologyGastroenterology and urologyClass IClass II
B & J Medical LLC
Contract manufacturer · Kendallville, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009973699 (openFDA record; or search FDA's registration database)
- FEI number
- 3009973699
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- B&J Medical (FDA owner/operator no. 10042587)
- Registered address
- 4268 East US Hwy 6, Kendallville, IN 46755
- Contract listings
- 62 device listings, 43 product codes, first listed Dec 11, 2012
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | May 4, 2023 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Dec 8, 2023 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Jul 25, 2023 |
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 25, 2020 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Apr 3, 2019 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jan 13, 2023 |
| GFC | Driver, Surgical, Pin | Class I | General and plastic surgery | Contract manufacturing | Jun 24, 2024 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 1, 2023 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 18, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Oct 26, 2015 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Nov 25, 2020 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 14, 2015 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jun 18, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Jun 22, 2023 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | May 18, 2023 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Sep 11, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 18, 2013 |
| HWD | Starter, Bone Screw | Class I | Orthopedic | Contract manufacturing | Dec 11, 2012 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Jun 24, 2024 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Feb 2, 2022 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Nov 25, 2020 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 13, 2023 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 2, 2022 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jan 28, 2021 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | Class I | General and plastic surgery | Contract manufacturing | Sep 23, 2019 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Sep 11, 2024 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 14, 2015 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jun 18, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jun 14, 2019 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Oct 26, 2015 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Oct 26, 2015 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Oct 26, 2015 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Nov 20, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jun 18, 2013 |
| OSN | Software For Diagnosis/Treatment | Class II | Orthopedic | Contract manufacturing | Jan 29, 2021 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Aug 24, 2016 |
| PFH | Venous Window Needle Guide | Class II | Gastroenterology and urology | Contract manufacturing | Aug 27, 2015 |
| PGM | Growing Rod System | Class II | Orthopedic | Contract manufacturing | Sep 23, 2025 |