FDA Registration
Active
🇺🇸 United States
Bradshaw Medical Inc.
Reg #: 3006846753
·
FEI: 3006846753
·
Expires 2026
Products
71
Proprietary Names
8
Establishment Types
2
Classifications
71
Registration Details
- Registration Name
- Bradshaw Medical Inc.
- Registration Number
- 3006846753
- FEI Number
- 3006846753
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10325 58th Place
- City
- Kenosha
- State
- WI
- ZIP
- 53144
- Country
- US
Owner / Operator
- Firm Name
- Bradshaw Medical Inc.
- Operator Number
- 10025925
- Address
- 89 South Commerce Way, Suite 99
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
- Correspondent
- Lisa Boyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur | HTX | Class 1 | Orthopedic | No | 2008-05-21 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-01-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-01-07 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2021-02-22 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2008-05-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2019-04-05 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2008-05-21 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2008-05-21 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-02-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-02-01 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2008-05-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-01 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-02-01 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-01 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2008-05-21 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2008-05-21 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2008-05-21 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-01-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2008-05-21 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2019-10-10 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-02-01 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-01-07 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2008-05-21 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-12-06 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-02-01 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2013-02-01 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-21 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2008-05-21 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-02-01 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-05-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-12-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-05-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Fork | HXE | Class 1 | Orthopedic | No | 2008-05-21 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2008-05-21 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-01-07 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2008-05-21 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2008-05-21 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2022-01-07 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2018-11-27 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2008-05-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2014-10-24 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2008-05-21 |
| File | HTP | Class 1 | Orthopedic | No | 2008-05-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2008-05-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2008-05-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-10-08 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2008-05-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2008-05-21 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2008-05-21 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2008-05-21 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2008-05-21 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2008-05-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2008-05-21 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2008-05-21 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2022-01-10 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2022-01-10 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2008-05-21 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2008-05-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2008-05-21 |
Proprietary Names
N/A
OFFSET CURVED OSTEOTOME, RIGHT
OFFSET CURVED OSTEOTOME, LEFT
LineSider Spinal System
Proprietary
SPW-RT550250
SPW-RT550500
ZISO46W1AN00530
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device