Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031917

FEI Number

3002929183

Entity Name

CLASSIC WIRE CUT COMPANY, INC.

City/State/Country

Valencia, CA, US

Establishment Address

28210 Constellation Rd, Valencia, CA 91355, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Classic Wire Cut Company, Inc. (Owner Number: 9039170)

Owner / Operator Contact Address

28210 Constellation Road, --, Valencia, CA 91355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knotilus+ Steathstation TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR Landmarx OPEN CURRETE SMALL JOINT CURRETE/DISSECTOR SMALL JOINT OPEN CURRETE CONVEX RASP STRAIGHT RASP CUFFED CURETTE CUPPED CURETTE TUNNEL RASP BIO-ANCHOR DRILL GUIDE SMALL JOINT DISSECTOR SMLL JOINT OPEN CURRETE CONCAVE RASP 3.4 SOFT TISSUE GRASPER 3.4 MENISCAL CRESCENT RIGHT 34mm SHOULDER S-T GRASPER W/O PCL Curved Rasp 3.4MM TIP BITER 45DEG LEFT 4.5 X 150MM Liberator Assembly 3.4MM SHOULDER S-T GRASPER W/ Rasp Assembly, Straight 3.4 PUNCH-STRAIGHT BIG BITE RASP 30DEG TOPSERRATIONS Osteotome Assembly P.C.L. CURVED RASP 2.7 BIG BITE 15 DEG UP 3.5MM SWITCHING STICK 155 X 3.5mm SEAHAWK RC SUTURE PASSER, LEFT Phoenix Drill Guide 155 X 3.5mm, SEAHAWK SUTURE PASSER, LEFT MediENT® Grasper SUTURE PASSER NEEDLE ASSEMBLY 155 X 3.5MM, SEAHAWK RC SUTURE PASSER, RIGHT 155 X 3.5mm, SEAHAWK SUTURE PASSER, RIGHT SPA RASP ASSEMBLY, (STRAIGHT) Knotilus+ Rasp 30 Degree Top and Bottom Tunnel Notcher Shaft Assembly 2.7 BASKET FORCEP RIGHT Small Closed Curette 4MM P.C.L. CURVEDCURETTE (CLOSED) 2.7 NARROW PUNCH LARGE OPEN CURETTE ASSEMBLY 3.4 UP SHAFT BIG BITE 3.4 ROTARY PUNCH 90DEG RIGHT LOOP KNOT PUSHER 3.4MM NARROW PUNCH Large Open Curette 2.7 ST GRASPERW/ RATCHET 3.4 NARROW 15 DEG UP 30 DEG RIGHT HOOK SCISSOR 2.7 BASKET FORCEP LEFT 3.4MM MENISCAL CRESCENT PUNCH LEFT RASP 30DEG BOTTM ANDTOP SERRATIONS 3.4 15 DEG UP 2.7 MICRO SCISSOR 2.7 BIG BITE BASKET SFT RASP 30 DEG BOTTOM S Rasp, 90 Degree, Bottom and Top 3.4 NARROW SCOOP ST TUNNEL NOTCHER ASSEMBLY 3.4 NAR SCOOP 30 DEGLEFT RASP 90DEG BOTTM ANDTOP SERRATIONS 4mm PCL, Curved Curette 3.4 MICRO SCISSOR 3.4 NAR SCOOP 30 DEGRIGHT 3.4MM 30 DEG LEFT MENISCAL 3.4MM 30 DEG RIGHT MENISCAL 3.4MM BIG BITE PUNCH30 DEG RIGHT BIO-ANCHOR LOCATOR 3.4MM GRASPER W/ RATCHET 3.4MM GRASPER Tunnel Rasp, 9.5mm 3.4MM HOOK SCISSORS PKG 2.7 SOFT TISSUE GRASPER 4 PITUATARY GRASPER RASP 30DEG BOTTOMSERRATIONS 30 DEG ANGLED HOOK SCISSOR LARGE CLOSED CURETTE ASSEMBLY 3.4 STRAIGHT Small Open Curette SUTURE CUTTER BACKBITER 3.4MM BIG BITE PUNCH 30 DEG LEFT Rasp Assembly, Convex 2.7MM 15 DEGREE SUTURE Retriever Large Closed Curette 3.4 HIP GRASPER Concave Rasp 3.4MM SOFT TISSUE GRASPER W/ RATCHET 2.7 UP SHAFT BIG BITE 3.4MM RAPTURE DYONICS STYLE Pkg., 2.7mm Straight Suture 3.4MM ROTARY PUNCH90 DEG LEFT PKG, 1.3mm X 35.6cm NITINOL GUIDE WIRE 3.4 45 DEG RIGHT SUTURE CUTTER XL LARGE SUTURE HOOKHANDLE ASSEMBLY Rasp, 30 Degree, Top Serration Tunnel Rasp, 9mm Ventera® SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT Talon SerpENT® MICA CrossCut Suture Cutter PROBE ASSEMBLY Small Straight ENT Suction EM ENT Elevator CVD Frontal ENT Suction EM ENT Suction Curette CVD 90 Degrees Scution ENT XIA 3 TI FRENCH BENDER ClearCut¿ Suture Cutter HEX CANNULATED DRIVER CONCEPT GRAFIX ES2 SPINAL SYSTEM PathSeeker Suture Passer Handle ExpresSew III Sutuer Passer w/o hook PathSeeker Suture Passer Right Hook Needle 8mm ExpresSew III AutoCapture Combo Kit PathSeeker Suture Passer Left Hook Needle 8mm ExpresSew III Needle ExpresSew III AutoCapture Loading Tool/Retention Plate PathSeeker Suture Passer Medium Crescent Needle 5mm ExpresSew III Sutuer Passer w/ hook ExpresSew III AutoCapture Flexible Suture Passer PathSeeker Suture Passer Straight Needle 8mm Expressew III AC+ Loader 1 pack Expressew III AC+ Loader 5 pack Reusable Obturator Phoenix Drill Guide Expressew III AC+ Big Dog Cutter Acufex TruNav Spear Passer Suture Needle CORTICAL GAUGE PUNCH KATANA SUTURE CUTTER Stryker Cross-Screw Instrumentation Set BIO-ANCHOR DRIVER REVO HOOK Spear Passer ICONIX All Suture Anchor System TwinLoop Anchor System TORNIER PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR AVS ANCHOR-C CERVICAL CAGE SYSTEM Oneport STEALTHSTATION CIRCULAR RASP ROTATOR BONE RASP PathSeeker Suture Passer Straight Needle 8mm PathSeeker Suture Passer Left Hook Needle 8mm ExpresSew Flexible Suture Passer FirstPass¿ Suture Passer EXPRESSEW III AUTO CAPTURE ARTHROPASS II EXPRESSEW AC SALES KIT Spectrum Autopass SELF-CAPTURE SUTURE PASSER TRUEPASS EXPRESSEW AC RETENTION BOARD AND LOADER ASSY NON-CAPTURE SUTURE PASSER TRUEPASS Expressew III AC+ Loader 1 pack Expressew III AC+ Loader 5 pack Expressew III AC+ ExpresSew II Suture Needle PathSeeker Suture Passer Handle Perimeter Mesh Cutter PathSeeker Suture Passer Right Hook Needle 8mm PathSeeker Suture Passer Medium Crescent Needle 5mm ExpresSew Suture Needle ExpresSew II Flexible Suture Passer PathSeeker SuturePass Hndle *EA ExpresSew III Needle ExpresSew III Sutuer Passer w/ hook ExpresSew III Sutuer Passer w/o hook Piranha EM Ostium Seeker EM Straight Suction Landmarx Framelock Device EM Registration Probe EM Straight Probe ENV Passive Curved Suction EM CVD 90 Degrees Suction Ferguson Suction Right Post Instrument ENV Frazier Suction Tracer Registration Passive Probe EM CVD 70 Degrees Suction Landmarx FESS Frame Kit Framelock Post Screwdriver EM Head Frame Landmarx Right Angle Curette Dual Post Olive Tip Suction Accessory LIBERATOR KNIFE Stealthstation Capstone Trial Knotilus+ TORNIER INSITE FT SUTURE ANCHOR Biosteon IntraLine PEEK IntraLine Biosteon Wedge Interference Screw System TORNIER, PITON FIXATION IMPLANT SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-10-27
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-07-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-01-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-01-03
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2013-01-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-21
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2013-01-22
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2013-01-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-22
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-01-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-08-21
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2015-10-19
HXB	Probe	Orthopedic	Class 1	888.4540	2013-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-02-29
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2015-01-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-03
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-02-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-02-15
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-10-08
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-22
HWQ	Passer	Orthopedic	Class 1	888.4540	2013-01-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-22
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-07-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-10-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-01-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-01-03

Official Correspondent

Marcy Martinez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Classic Wire Cut Company, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

Registration Number	Establishment Name	Location
3005706667	TURNER MEDICAL INC.	Athens, AL, US
3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR
1722511	ORTHO DEVELOPMENT CORP.	DRAPER, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031917. Last updated year: 2026. Please use registration number 2031917 when referencing this establishment in official correspondence.