FDA Registration
Active
🇺🇸 United States
RF CANN EXTRCTN ADAPTER 5
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
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
- K142281
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 |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2016-06-20 |
Proprietary Names
RF CANN EXTRCTN ADAPTER 5
RF MOD 3.5MM HEX SCREWDRIVER
LONG CM LAG SCW PIN CANN
CM LAG SCREW REAMER 3.2MM ID
RF TAPER REAMER 14.5MM
CM SCREWDRIVER 3.5MM HEX
LONG CM LAG SCW PIN CANN 3.2MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)