FDA Registration
Active
🇺🇸 United States
B & G MFG. CO.
Reg #: 3004188066
·
FEI: 3004188066
·
Expires 2026
Products
36
Proprietary Names
7
Establishment Types
1
Classifications
36
Registration Details
- Registration Name
- B & G MFG. CO.
- Registration Number
- 3004188066
- FEI Number
- 3004188066
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3067 UNIONVILLE PIKE
- City
- HATFIELD
- State
- PA
- ZIP
- 19440
- Country
- US
Owner / Operator
- Firm Name
- B&G Manufacturing Company
- Operator Number
- 9058527
- Address
- 3067 UNIONVILLE PIKE, --
- City
- Hatfield
- State
- PA
- Postal Code
- 19440
- Country
- US
- Correspondent
- Scott Reiff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-04-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-04-15 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-04-15 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-04-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-04-15 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-12-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-12-29 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2016-12-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-12-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2016-12-29 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2023-03-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2016-03-21 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-07 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2022-01-05 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-01-05 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-04-15 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-03-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-03-27 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-03-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-04-07 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2020-12-23 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2026-01-14 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2023-03-27 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2023-03-27 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-04-15 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2023-03-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-04-15 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2019-12-12 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2022-01-05 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-04-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2026-01-14 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2013-04-15 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-03-27 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2026-01-14 |
Proprietary Names
ODP - Intervertebral fusion device with bone graft, cervical
COALITION MIS
Intervertebral fusion device
UNIFY TM Dynamic Anterior Cervical Plate System
CREO Stabilization System
Line Extension to: Stalif M Stalif M-Ti
Excelsius GPS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)