FDA Registration
Active
🇺🇸 United States
TAP, Bone
Reg #: 3026576110
·
FEI: 3026576110
·
Expires 2025
Products
1
Proprietary Names
27
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Precision Edge Surgical Products, LLC
- Registration Number
- 3026576110
- FEI Number
- 3026576110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1910 N. Wayne Street
- City
- Angola
- State
- IN
- ZIP
- 46703
- Country
- US
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 |
|---|---|---|---|---|---|
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-04-17 |
Proprietary Names
TAP, Bone
2.4MM TAP AO - 30MM
3.5MM PERC CANN LOCK SCREW TAP
HERBERT tap
5.5MM SINGLE LEAD TAP, AO
4.5MM SINGLE LEAD TAP, AO
TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
CANN TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
12MM EXTENDED CANULATED TAP
TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
CANN TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
11MM EXTENDED CANULATED TAP
CANN TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 3.5MM DUAL CORE SCREWS 6MM HXC
TAP FOR 5.5MM DUAL CORE SCREWS 6MM HXC
CANN TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 9MM DUAL CORE SCREWS 6MM HXC
TAP FOR 8MM DUAL CORE SCREWS 6MM HXC
UNIVERSAL JOINT TAP FOR 4.5MM OCCIPITAL SCREWS
TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW
TAP FOR 6MM DUAL CORE SCREWS 6MM HXC
APEX Post Tap
TAP FOR 4MM DUAL CORE SCREWS 6MM HXC
TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 5MM DUAL CORE SCREWS 6MM HXC
TAP FOR 7MM DUAL CORE SCREWS 6MM HXC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)