FDA Registration
Active
🇺🇸 United States
PRECISION FORMS, INC.
Reg #: 3010041993
·
FEI: 3010041993
·
Expires 2026
Products
17
Proprietary Names
3
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- PRECISION FORMS, INC.
- Registration Number
- 3010041993
- FEI Number
- 3010041993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 97 Decker Rd
- City
- Butler
- State
- NJ
- ZIP
- 07405
- Country
- US
Owner / Operator
- Firm Name
- Precision Forms, Inc.
- Operator Number
- 10043073
- Address
- 97 Decker Road
- City
- Butler
- State
- NJ
- Postal Code
- 07405
- Country
- US
- Correspondent
- William Sulski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-23 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-23 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-23 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-23 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-01-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-23 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-01-23 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2013-04-05 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2013-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-04-05 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2013-01-23 |
Proprietary Names
MRS
Restoris® PST ® Acetabular Shell
Restoris® ø6.5mm Bone Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)