FDA Registration
Active
🇺🇸 United States
Precision Edge Surgical Products Co LLC
Reg #: 3013820441
·
FEI: 3013820441
·
Expires 2026
Products
12
Proprietary Names
372
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- Precision Edge Surgical Products Co LLC
- Registration Number
- 3013820441
- FEI Number
- 3013820441
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1448 Lexamar Drive
- City
- Boyne City
- State
- MI
- ZIP
- 49712
- 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 |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2021-10-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-10-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-10 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-09-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-11-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-02-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-04-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-10 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2020-05-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-14 |
Proprietary Names
4.6MM X 30CM SOLID DRILL
18MM CUP REAMER
16MM CUP REAMER
26MM CUP REAMER
26MM CONE REAMER
22MM PROXIMAL REAMER (F) QC
22MM DISTAL REAMER (M) QC
18MM PROXIMAL REAMER (F) QC
24MM DISTAL REAMER (M) QC
16MM DISTAL REAMER (M) QC
18MM DISTAL REAMER (M) QC
SROM REAMER BLUNT 18.5MM STR
CANAL REAMER 19.5
3.9MM/6MM DRILL-REAMER QC/145MM FOR 5MM ASLS
16MM PROXIMAL REAMER (F) QC
14MM DISTAL REAMER (M) QC
CANAL REAMER 16.5
24MM PROXIMAL REAMER (F) QC
CANAL REAMER 10.5
CANAL REAMER 12.5
SROM TRI BAND CONE REAMER 21
SROM REAMER BLUNT 17.5MM STR
8.5MM S+B2:B30TRAIGHT BULLET NOSE RMR
CANAL REAMER 8
16.5MM MEDULLARY REAMER HEAD
20MM DISTAL REAMER (M) QC
CANAL REAMER 15.5
CANAL REAMER 19
SROM REAMER BLUNT 13.5MM STR
15.5MM MEDULLARY REAMER HEAD
18MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 16.5MM STR
RECLAIM CLEAR OUT REAMER
17MM MEDULLARY REAMER HEAD
20MM PROXIMAL REAMER (F) QC
CANAL REAMER 13
14MM PROXIMAL REAMER (F) QC
11MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 20.5MM STR
SROM TRI BAND CONE REAMER 29
CANAL REAMER 18
17.5MM MEDULLARY REAMER HEAD
CANAL REAMER 14
SROM REAMER BLUNT 11.5MM STR
CANAL REAMER 14.5
CANAL REAMER 17.5
CANAL REAMER 13.5
19MM MEDULLARY REAMER HEAD
CANAL REAMER 9
CANAL REAMER 9.5
13MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 23MM STR
CANAL REAMER 17
11.5MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 22.5MM STR
SROM REAMER BLUNT 10.5MM STR
14.5MM MEDULLARY REAMER HEAD
CANAL REAMER 8.5
SROM REAMER BLUNT 15.5MM STR
13.5MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 19.5MM STR
SROM TRI BAND CONE REAMER 19
SROM TRI BAND CONE REAMER 15
SROM REAMER BLUNT 9.5MM STR
CANAL REAMER 15
18.5MM MEDULLARY REAMER HEAD
14MM MEDULLARY REAMER HEAD
12MM MEDULLARY REAMER HEAD
CANAL REAMER 11.5
C-Stem Canal Reamer 13Mm
SROM REAMER BLUNT 12.5MM STR
SROM REAMER BLUNT 21.5MM STR
16MM MEDULLARY REAMER HEAD
SROM REAMER BLUNT 22MM STR
SROM REAMER BLUNT 14.5MM STR
CANAL REAMER 11
15MM MEDULLARY REAMER HEAD
SROM TRI BAND CONE REAM 17-12D
12.5MM MEDULLARY REAMER HEAD
CANAL REAMER 16
CANAL REAMER 12
MBT REV PRIMARY CONICAL REAMER
SROM TRI BAND CONE REAM 17-14B
SROM TRI BAND CONE REAMER 31
SROM TRI BAND CONE REAMER 23
CANAL REAMER 10
Opening Reamer 13mm
C-Stem Canal Reamer 15Mm
Opening Reamer 14mm
C-Stem Canal Reamer 20Mm
C-Stem Canal Reamer 14Mm
4.6mm X-Post Reamer
Instr, CrossTIE Reamer - 2.2mm x 82mm
Instr, MotoBAND 2mm Reamer
Instr, DynaForce Reamer 2.2mm
Instr, DynaForce Reamer 3mm
Instr, DynaForce Reamer 2.5mm
15MM DIA REAMER
Instr, Bone Screw Reamer, Cann, 3mm
10MM DIA REAMER
22MM DIA REAMER
9MM DIA REAMER
21MM DIA REAMER
Instr, MotoBAND 2.5mm Reamer
11MM DIA REAMER
20MM CONE REAMER
Instr, MotoBAND 2.5mm Long Reamer
16MM DIA REAMER
19MM DIA REAMER
14MM CONE REAMER
14MM DIA REAMER
Instr, Bone Screw Reamer, Cann, 4.9mm
24MM CUP REAMER
23MM DIA REAMER
18MM DIA REAMER
24MM CONE REAMER
20MM DIA REAMER
17MM DIA REAMER
Instr, Bone Screw Reamer, Cann, 3.5mm
14MM CUP REAMER
Instr, CrossTIE Reamer - 2.5mm x 82mm
20MM CUP REAMER
Instr, DynaForce Reamer 3.2mm
Instr, CrossTIE Reamer - 3mm x 82mm
12MM DIA REAMER
13MM DIA REAMER
24MM DIA REAMER
22MM CONE REAMER
Instr, CrossTIE Reamer - 2.7mm x 82mm
Instr, DynaForce Reamer 2.7mm
18MM CONE REAMER
16MM CONE REAMER
22MM CUP REAMER
Drill 1.9MM
QC DRL BIT. 2.5MM DIA 125MM
STR S DRL BIT 4.5MM DIA 12.7CM
QC DRL BIT. 2MM DIA 125MM
QC DRL BIT. 2.7MM DIA 100MM
STR S DRL BIT 2.5MM DIA 12.7CM
DRILL 1.5MM DIA
STR S DRL BIT 3.5MM DIA 12.7CM
QC DRL BIT. 1.1MM DIA 60MM
HERBERT pilot drill 2
QC DRL BIT. 1.5MM DIA 110MM
QC DRL BIT. 2.7MM DIA 125MM
CANN PILOT DRILL 5.5MM DIA
STR S DRL BIT 2MM DIA 12.7CM
HERB BONE SCR PILOT POW DRILL 3.2MM DIA
Q/C DRILL 5MMDIAX195MM LONG
2MM CANNULATED DRILL W/QUICK COUPLING, 150MM
QC DRL BIT. 4.5MM DIA 195MM
QC DRL BIT. 1.5MM DIA 85MM
CANN PILOT DRILL 3.8MM DIA
CANN MAIN DRILL 3.1MM DIA
QC DRL BIT. 4.5MM DIA 145MM
Q/C DRILL 2.5MM DIA XLNG
CANN MAIN DRILL 4.6MM DIA
QC DRL BIT. 3.5MM DIA 110MM
QC DRL BIT. 3.2MM DIA 195MM
STR S DRL BIT 2.7MM DIA 12.7CM
CANNULATED DRILL, 11MM
CANNULATED DRILL, 7MM
CANNULATED DRILL, 9MM
CANNULATED DRILL, 4MM
CANNULATED DRILL, 10MM
CANNULATED DRILL, 8MM
CANNULATED DRILL, 6MM
CANNULATED DRILL, 5MM
LARGE SCREWDRIVER JAWS
Long Screw driver with retention hex (3.5mm)
Hex Driver (5mm/8mm)
Long Removal and Insertion Hex
Short Screw Driver with Retention (3.5mm)
Long Screw Hex Driver
Short Screw Hex Driver(3.5mm)
Instr, 2mm Hex Driver Cannulated
Cannulated T6 Driver
Instr, H10 Driver Cannulated
Instr, Bone Screw Screwdriver, TX25
DRILL BIT, SOLID CORE, AO/QC, 4.5MM
TAP, Bone
HERBERT tap
3.5MM PERC CANN LOCK SCREW TAP
2.4MM TAP AO - 30MM
4.5MM SINGLE LEAD TAP, AO
5.5MM SINGLE LEAD TAP, AO
APEX Post Tap
CANN TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 6MM DUAL CORE SCREWS 6MM HXC
CANN TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW
TAP FOR 5.5MM DUAL CORE SCREWS 6MM HXC
12MM EXTENDED CANULATED TAP
TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 7MM DUAL CORE SCREWS 6MM HXC
TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 8MM DUAL CORE SCREWS 6MM HXC
TAP FOR 9MM DUAL CORE SCREWS 6MM HXC
UNIVERSAL JOINT TAP FOR 4.5MM OCCIPITAL SCREWS
TAP FOR 6MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 3.5MM DUAL CORE SCREWS 6MM HXC
TAP FOR 4MM DUAL CORE SCREWS 6MM HXC
TAP FOR 7MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
5.5MM TriLEAP JONES SCREW TAPS
CANN TAP FOR 5MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
TAP FOR 5MM DUAL CORE SCREWS 6MM HXC
11MM EXTENDED CANULATED TAP
CANN TAP FOR 4MM DUAL CORE SCREWS SINGLE LEAD 6MM HXC
6.5MM TriLEAP JONES SCREW TAPS
4.5MM TriLEAP JONES SCREW TAPS
SHARK SCREW DRILL 2.85MM
2.7MM X 13 CM SOLID OVERDRILL
2.4 MM X 14 CM SS DRILL
2MM X 14 CM SOLID DRILL
Purple 5mm Stepped Twist Drill X Length 370mm (Use 5mm Locking Bolt)
Yellow 4.25mm Drill X Length 165mm (Use 5mm Locking Screw)
Blue 6mm Stepped Twist Drill X Length 370mm (Use 6mm Locking Bolt)
Yellow 4.25mm Twist Drill X Length 370mm (Use 5mm Locking Screw)
3.5MM X 10CM SOLID DRILL
2MM X 119MM DRILL, CANN
3.5MMX13CM SOLID OVERDRILL
DRILL BITS SHORT 3.3MM
DRILL, 12MM CANN, LQC, LONG
4.2MMX14CM SOLID OVERDRILL
2.4MM X 17.25 CM SOLID DRILL
2.8MM X 111.5CM SOLID DRILL
Yellow 4.25mm Twist Drill X Length 300mm (Use 5mm Locking Screw) R
Orange 4.9mm Twist Drill X Length 370mm (Use 6mm Locking Screw)
4.3MM X 10CM SOLID DRILL
2.2MM X 129MM DRILL, CANN
2.4MM X 16.5 CM SOLID DRILL
4MM X 11CM CANNULATED OVERDRILL
4.6mm x 34cm Solid Drill
3.5MM X 10CM CANNUALTED DRILL
4.3MM X 10CM CANNULATED DRILL
4.4MM X 160 MM DRILL 6 MM HALF PINS
3.5MM X 20CM CANNULATED DRILL
3.4MM X 160MM 5 HALF PINS
SOLID 3.6MM X 16CM SS
DRILL, 12MM CANN, LQC, SHORT
2.4MM X 18 CM SS SOLID
2.4MM X 95 MM DRILL 4 HALF PINS
2mm Cannulated Drill
4.6MM X 25CM CANNULATED DRILL
3 CANNULATED DRILL
5MM CANNULATED DRILL BIT LRG QC/300MM/200MM CALIBRATION
3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
1.6MM DRILL BIT F/ STANDARD TECH
1.7MM CANNULATED DRILL BIT/QC 100MM
1.8MM DRILL BIT HEX COUPLING WITH 10MM STOP/82MM
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
5MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
5MM THREE-FLUTED DRILL BIT QC/356MM/126MM CALIBRATION
1.8MM DRILL BIT HEX COUPLING WITH 22MM STOP/88MM
2.5mm Cannulated Drill
12MM CANNULATED DRILL BIT LARGE QC/190MM
3.8MM DRILL BIT WITH 20MM STOP QC
2.7MM DRILL BIT F/ STANDARD TECH
Long Drill Pin, Large
2.5mm Solid Drill with Stop
1.8MM DRILL BIT HEX COUPLING WITH 12MM STOP/82MM
3.5MM DRILL BIT F/ LAG TECH
Cannulated Drill - 3.4mm
1.8MM DRILL BIT HEX COUPLING WITH 14MM STOP/82MM
DRILL BIT / CANN /12.8MM LARGE QUICK COUPLING
17MM CANNULATED DRILL BIT LARGE QC/280MM
5MM CANNULATED DRILL BIT/QC 200MM
2.5MM CANNULATED DRILL
Instr, Head Drill 3mm Cannulated
2.5MM DRILL BIT F/ LAG TECH
5MM/7.3MM STEPPED DRILL BIT 10MM STEP FOR SCFE SCREW
DRILL BIT / CANN /11.2MM LARGE QUICK COUPLING
1.8MM DRILL BIT HEX COUPLING WITH 24MM STOP/88MM
3MM CANNULATED DRILL
5MM CANNULATED DRILL BIT LARGE QC/300MM
1.8MM DRILL BIT HEX COUPLING WITH 20MM STOP/88MM
Peg Drill, 4.2mm
DRILL PIN 2.5 X 200
Solid Drill with Stop
DRILL BIT/ CANNULATED 12MM LONG
Cannulated Drill - 3mm
4MM TRILEAP CANN DRILL BIT
15MM CANNULATED DRILL BIT LARGE QC/280MM
2MM DRILL BIT F/ STANDARD TECH
3MM TRILEAP CANN DRILL BIT
1.8MM DRILL BIT HEX COUPLING WITH 18MM STOP/82MM
5MM TRILEAP CANN DRILL BIT
2MM DRILL BIT F/ LAG TECH
15MM CANNULATED DRILL BIT LARGE QUICK COUPLING/330MM
DRILL PIN AXIS, 2 X 150
4.5MM CANNULATED DRILL BIT JC/WITH 135MM STOP/165MM
SHARK SCREW DRILL 3.25MM
Instr, Drill Bit 2.2mm Cannulated
4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
DRILL BIT/ CANNULATED/ 12MM SHORT
1.8MM DRILL BIT HEX COUPLING WITH 16MM STOP/82MM
4.5MM CANNULATED DRILL BIT/JC 233MM
8MM CANNULATED DRILL BIT LARGE QC/350MM
5MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW
4.3MM CANNULATED DRILL BIT/QC 200MM
SHARK SCREW DRILL 3.7MM
SHARK SCREW DRILL 4.2MM
15MM Fluted STM Tib Drill
DRILL PIN AXIS, 2 X 200
DRILL PIN AXIS, 2.5 X 150
6.5 HEADLESS, CANN C'SINK
Instr, Countersink, 4mm Headed Screw
Instr, Countersink, 3mm Headed Screw
Instr, Countersink, 5 / 6.5mm HD Screw
CANNULATED COUNTERSINK FOR 2.4MM CANNULATED SCREWS
Pigtail Hamstring Tendon Stripper, Open end, 7mm
INNER CHANNEL REAMER SLEEVE
INNER CHANNEL REAMER
Suprapatellar Anchoring Protection Sleeve
Green Outer Drill Sleeve (Length 129mm)
Tibial Infrapatellar Connecting Bolt
Fracture Reduction Tool
Green Outer Drill Sleeve
Insert Retainer
Orange 5.25mm Drill Sleeve
Obturator
Suprapatellar Trocar
Tube Tissue Protector
Suprapatellar K-Wire Guide
4.2MM CORTICAL DRILL
Femur Connecting Bolt
Flexible driver with retention Hex
Trocar 8mm x Length 220mm
Blue 6mm Drill Sleeve
Trocar 8mm x Length 150mm
Suprapatellar Standard Protection Sleeve Assembly
Suprapatellar AO Mount Anchor Pin
Tibial Suprapatellar Connecting Bolt
Femoral Nail Extraction Bolt
4.25mm Drill Sleeve, Yellow (Length 138.5mm)
Purple 5mm Drill Sleeve
Tibia Adapter Bolt
RETENTION HEX FLEXIBLE DRIVER
Tibia Infrapatellar Insert Retainer
Tibial Suprapatellar Insert Retainer
Suprapatellar Protection Sleeve Handle Connector
Mallet Guide
Yellow 4.25mm Drill Sleeve
ET HEX SCR DRIVER ASSY, SHORT
RET HEX SCR DRIVER ASSY, LONG
YELLOW TROCAR, 227MM
BLUE TROCAR, 227MM
K-WIRE SLEEVE
ORANGE PURPLE TROCAR, 227MM
PEDICLE MARKER-BEADED
1.6 SLV F/ 2MM DRILL GUIDE
CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS
GRYPHON Flex Knotless Anchor Obturator
3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX
2.7 SLV INS F/3.5MM DRILL GUIDE
STRAIGHT BALL TIP PROBE-SMALL
SMALL PEDICLE MARKER-LONG BEADED
PEDICLE MARKER-LONG BEADED
SHART SCREW DRILL 2.85
2 SLV F/ 2.5MM DRILL GUIDE
IM REDUCTION TOOL/CURVED WITH QUICK COUPLING
IM NAIL REDUCTION TOOL 7.5MM SHAFT WITH CURVED TIP
SMALL PEDICLE MARKER-BEADED
SHARK SCREW DRILL 4.2
SHARK SCREW DRILL 3.25
3.2MM TROCAR FOR RECON LOCKING
SHARK SCREW DRILL 3.7
1.6mm KWIRE HANDLHELD DRILL GUIDE
ACORN REAMER 9MM
DRILL BIT,STAPLE,AO/QC, 1.6MM
DRILL BIT,STAPLE,AO/QC,1.8MM
DRILL BIT, STAPLE,LONG 2MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Manufacture Medical Device