FDA.reportPublic FDA data

Guidewire Kit

Primary DI
10855068008119
Brand
Guidewire Kit
Company
CURVAFIX, INC.
Model
CGK-001
Catalog number
CGK-001
Device description
A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidewire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix IM Implant.
Published
2021-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855068008119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085506800811910855068008119

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, single-useA sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425-276-8800support@curvafix.com

Regulatory Flags#

DUNS number
039779098
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850070500101Core Wire, Removal Tool, ReusableCRT-003CRT-0032026-10-29
10855068008935Removal Tool Core Wire, DisposableRCW-001RCW-0012026-10-29
10850070500125CurvaFix® Low Profile Implant9.5 mm x 90 mmCRS-095-090-LP2025-10-22
10850070500132CurvaFix® Low Profile Implant9.5 mm x 100 mmCRS-095-100-LP2025-10-22
10850070500149CurvaFix® Low Profile Implant9.5 mm x 110 mmCRS-095-110-LP2025-10-22
10850070500156CurvaFix® Low Profile Implant9.5 mm x 120 mmCRS-095-120-LP2025-10-22
10850070500163CurvaFix® Low Profile Implant9.5 mm x 130 mmCRS-095-130-LP2025-10-22
10850070500170CurvaFix® Low Profile Implant9.5 mm x 140 mmCRS-095-140-LP2025-10-22
10850070500187CurvaFix® Low Profile Implant9.5 mm x 150 mmCRS-095-150-LP2025-10-22
10850070500194CurvaFix® Low Profile Implant9.5 mm x 160 mmCRS-095-160-LP2025-10-22
10850070500200CurvaFix® Low Profile Implant9.5 mm x 170 mmCRS-095-170-LP2025-10-22
10850070500217CurvaFix® Low Profile Implant9.5 mm x 180 mmCRS-095-180-LP2025-10-22
10850070500224CurvaFix® Low Profile Implant9.5 mm x 190 mmCRS-095-190-LP2025-10-22
10850070500231CurvaFix® Low Profile Implant9.5 mm x 200 mmCRS-095-200-LP2025-10-22
10850070500248CurvaFix® Low Profile Implant9.5 mm x 210 mmCRS-095-210-LP2025-10-22
10850070500255CurvaFix® Low Profile Implant7.5 mm x 90 mmCRS-075-090-LP2025-10-22
10850070500262CurvaFix® Low Profile Implant7.5 mm x 100 mmCRS-075-100-LP2025-10-22
10850070500279CurvaFix® Low Profile Implant7.5 mm x 110 mmCRS-075-110-LP2025-10-22
10850070500286CurvaFix® Low Profile Implant7.5 mm x 120 mmCRS-075-120-LP2025-10-22
10850070500293CurvaFix® Low Profile Implant7.5 mm x 130 mmCRS-075-130-LP2025-10-22

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