FDA Registration
Active
🇺🇸 United States
OBERG MEDICAL PRODUCTS COMPANY
Reg #: 3003639920
·
FEI: 3003639920
·
Expires 2026
Products
33
Proprietary Names
11
Establishment Types
1
Classifications
33
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Registration Details
- Registration Name
- OBERG MEDICAL PRODUCTS COMPANY
- Registration Number
- 3003639920
- FEI Number
- 3003639920
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 273 N Pike Rd
- City
- Sarver
- State
- PA
- ZIP
- 16055
- Country
- US
Owner / Operator
- Firm Name
- Oberg Industries LLC
- Operator Number
- 9047380
- Address
- 273 North Pike Road
- City
- Sarver
- State
- PA
- Postal Code
- 16055
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-02-20 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-02-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2014-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2014-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-04-07 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2014-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2014-04-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2017-10-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-10-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-02-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-20 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-02-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-03-23 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-03-23 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2017-09-07 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-05-26 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-03-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-06-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-02-20 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-02-20 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2016-06-27 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-10-23 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2013-02-20 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-02-20 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2017-10-31 |
Proprietary Names
Stryker - Triathlon Instruments Patella Stylus (6541-3-601) (1001880)
Stryker - Triathlon Instruments Patella Clamp (6541-3-600) (1001879)
Stryker - Triathlon Instruments Distal Capture Assembly (6541-1-723) (1000056)
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Drill Guide 45/60 Osteolock
EXTRAMEDULLARY ARCH 00512558100
ROTATIONAL ALIGNMENT GUIDE 00598755101
NEXGEN COMPLETE KNEE SOLUTION TIBIAL RESECTION GUIDE 50 INCH THICKNESS 00597758400
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Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)