FDA Registration
Active
🇺🇸 United States
PRECISION EDGE SURGICAL PRODUCTS COMPANY
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
8
Proprietary Names
0
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- PRECISION EDGE SURGICAL PRODUCTS COMPANY
- Registration Number
- 1833986
- FEI Number
- 1000139987
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 415 W 12th Ave
- City
- Sault Sainte Marie
- State
- MI
- ZIP
- 49783
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110940
Owner / Operator
- Firm Name
- Precision Edge Surgical Products Company
- Operator Number
- 10042577
- Address
- 415 West 12th Avenue
- City
- Sault Sainte Marie
- State
- MI
- Postal Code
- 49783
- Country
- US
- Correspondent
- Angela Gorsuch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2012-12-10 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2012-12-10 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)