FDA Registration
Active
🇺🇸 United States
Instr, DynaForce Reamer 2.5mm
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
132
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
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 |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-10 |
Proprietary Names
Instr, DynaForce Reamer 2.5mm
22MM CONE REAMER
15MM DIA REAMER
12MM DIA REAMER
23MM DIA REAMER
22MM DIA REAMER
11MM DIA REAMER
21MM DIA REAMER
26MM CONE REAMER
18MM DIA REAMER
20MM CONE REAMER
14MM CUP REAMER
16MM CUP REAMER
26MM CUP REAMER
14MM CONE REAMER
20MM PROXIMAL REAMER (F) QC
24MM DISTAL REAMER (M) QC
22MM DISTAL REAMER (M) QC
CANAL REAMER 11.5
SROM REAMER BLUNT 12.5MM STR
SROM REAMER BLUNT 9.5MM STR
16MM MEDULLARY REAMER HEAD
18MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 21.5MM STR
11MM MEDULLARY REAMER HEAD
SROM TRI BAND CONE REAMER 29
CANAL REAMER 18
CANAL REAMER 12.5
CANAL REAMER 9.5
12.5MM MEDULLARY REAMER HEAD
8.5MM S+B2:B30TRAIGHT BULLET NOSE RMR
CANAL REAMER 8
14MM PROXIMAL REAMER (F) QC
SROM REAMER BLUNT 14.5MM STR
CANAL REAMER 16.5
18MM PROXIMAL REAMER (F) QC
SROM TRI BAND CONE REAMER 31
CANAL REAMER 19.5
15.5MM MEDULLARY REAMER HEAD
24MM PROXIMAL REAMER (F) QC
16MM PROXIMAL REAMER (F) QC
SROM TRI BAND CONE REAM 17-14B
SROM REAMER BLUNT 18.5MM STR
CANAL REAMER 13.5
14.5MM MEDULLARY REAMER HEAD
CANAL REAMER 19
SROM REAMER BLUNT 13.5MM STR
22MM PROXIMAL REAMER (F) QC
19MM MEDULLARY REAMER HEAD
16MM DISTAL REAMER (M) QC
SROM TRI BAND CONE REAMER 23
SROM REAMER BLUNT 22.5MM STR
RECLAIM CLEAR OUT REAMER
SROM REAMER BLUNT 11.5MM STR
3.9MM/6MM DRILL-REAMER QC/145MM FOR 5MM ASLS
20MM DISTAL REAMER (M) QC
18MM DISTAL REAMER (M) QC
14MM DISTAL REAMER (M) QC
13.5MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 22MM STR
11.5MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 15.5MM STR
CANAL REAMER 14
SROM TRI BAND CONE REAMER 19
CANAL REAMER 15
CANAL REAMER 10.5
CANAL REAMER 17
17.5MM MEDULLARY REAMER HEAD
CANAL REAMER 15.5
16.5MM MEDULLARY REAMER HEAD
CANAL REAMER 9
CANAL REAMER 13
SROM REAMER BLUNT 16.5MM STR
SROM TRI BAND CONE REAM 17-12D
SROM REAMER BLUNT 17.5MM STR
C-Stem Canal Reamer 13Mm
CANAL REAMER 16
SROM REAMER BLUNT 23MM STR
SROM REAMER BLUNT 20.5MM STR
12MM MEDULLARY REAMER HEAD
CANAL REAMER 11
13MM MEDULLARY REAMER HEAD
CANAL REAMER 10
SROM REAMER BLUNT 10.5MM STR
14MM MEDULLARY REAMER HEAD
CANAL REAMER 17.5
SROM TRI BAND CONE REAMER 21
CANAL REAMER 8.5
15MM MEDULLARY REAMER HEAD
CANAL REAMER 14.5
18.5MM MEDULLARY REAMER HEAD
C-Stem Canal Reamer 15Mm
C-Stem Canal Reamer 14Mm
SROM REAMER BLUNT 19.5MM STR
17MM MEDULLARY REAMER HEAD
CANAL REAMER 12
SROM TRI BAND CONE REAMER 15
MBT REV PRIMARY CONICAL REAMER
Opening Reamer 14mm
C-Stem Canal Reamer 20Mm
Opening Reamer 13mm
Instr, DynaForce Reamer 3.2mm
Instr, Bone Screw Reamer, Cann, 4.9mm
Instr, CrossTIE Reamer - 2.2mm x 82mm
Instr, MotoBAND 2mm Reamer
Instr, DynaForce Reamer 2.7mm
Instr, DynaForce Reamer 2.2mm
24MM DIA REAMER
9MM DIA REAMER
Instr, CrossTIE Reamer - 2.7mm x 82mm
14MM DIA REAMER
Instr, Bone Screw Reamer, Cann, 3mm
4.6mm X-Post Reamer
Instr, CrossTIE Reamer - 2.5mm x 82mm
24MM CONE REAMER
13MM DIA REAMER
18MM CUP REAMER
16MM DIA REAMER
Instr, MotoBAND 2.5mm Long Reamer
20MM DIA REAMER
20MM CUP REAMER
16MM CONE REAMER
18MM CONE REAMER
24MM CUP REAMER
10MM DIA REAMER
Instr, MotoBAND 2.5mm Reamer
Instr, CrossTIE Reamer - 3mm x 82mm
Instr, Bone Screw Reamer, Cann, 3.5mm
Instr, DynaForce Reamer 3mm
17MM DIA REAMER
19MM DIA REAMER
22MM CUP REAMER
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)