FDA Registration
Active
🇺🇸 United States
b-ONE Ortho Corp.
Reg #: 3042508254
·
FEI: 3042508254
·
Expires 2026
Products
24
Proprietary Names
0
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- b-ONE Ortho Corp.
- Registration Number
- 3042508254
- FEI Number
- 3042508254
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 159 Dwight Pl
- City
- Fairfield
- State
- NJ
- ZIP
- 07004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202768
Owner / Operator
- Firm Name
- b-ONE Ortho, Corp.
- Operator Number
- 10059458
- Address
- 3 Wing Drive Suite #259
- City
- Cedar Knolls
- State
- NJ
- Postal Code
- 07927
- Country
- US
- Correspondent
- Imants Liepins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-13 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-01-28 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2019-01-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-01-28 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2019-01-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2022-02-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-02-03 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-01-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-01-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-12-03 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2019-01-28 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-06-01 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-01-28 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2019-01-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-01-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-10-30 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-01-28 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2019-01-28 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-01-28 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-01-28 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-10-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-01-28 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2019-01-28 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility