FDA.reportPublic FDA data

Removal Tool Core Wire, Disposable

Primary DI
10855068008935
Brand
Removal Tool Core Wire, Disposable
Company
CURVAFIX, INC.
Model
RCW-001
Catalog number
RCW-001
Device description
Wire that is used with the Square Drive and Spanner (Removal Tool). Narrow ends of wire fit in Implant cannula. Wire then tapers to be larger than Implant cannula. Core Wire has one smooth taper and one threaded taper. Mallet strikes on the wire into the Implant creates interference fit with Implant cannula, providing a method of axial pull for the Implant during removal. The Core Wire is a single-use component that is supplied gamma sterilized and ready to use. It is provided in a sterile barrier pouch inside of a unit shelf storage carton. The single-use Core Wire carton includes one (1) Core Wire.
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855068008935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085506800893510855068008935

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
039779098
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850070500101Core Wire, Removal Tool, ReusableCRT-003CRT-0032026-10-29
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
10850070500309CurvaFix® Low Profile Implant7.5 mm x 140 mmCRS-075-140-LP2025-10-22

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