Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013820441

FEI Number

3013820441

Entity Name

Precision Edge Surgical Products Co LLC

City/State/Country

Boyne City, MI, US

Establishment Address

1448 Lexamar Drive, Boyne City, MI 49712, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Precision Edge Surgical Products Company (Owner Number: 10042577)

Owner / Operator Contact Address

415 West 12th Avenue, Sault Sainte Marie, MI 49783, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 2MM CANNULATED DRILL W/QUICK COUPLING, 150MM 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 APEX Post Tap 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 TAP FOR 7MM DUAL CORE SCREWS 6MM HXC 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 TAP FOR 8MM DUAL CORE SCREWS 6MM HXC STRAIGHT BALL TIP PROBE-SMALL SMALL PEDICLE MARKER-LONG BEADED TAP FOR 9MM DUAL CORE SCREWS 6MM HXC 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-09-13
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-09-14
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-11-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-02-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-08-23
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-08-23
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-10
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-05-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-07-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-14

Official Correspondent

Angela Gorsuch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Edge Surgical Products Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1833986	PRECISION EDGE SURGICAL PRODUCTS COMPANY	Sault Sainte Marie, MI, US
3026576110	Precision Edge Surgical Products, LLC	Angola, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013820441. Last updated year: 2026. Please use registration number 3013820441 when referencing this establishment in official correspondence.