FDA.reportPublic FDA data

Exchange K-Wire Ø2.4mm x 450mm - Blunt Tip

Primary DI
07540161800215
Brand
Exchange K-Wire Ø2.4mm x 450mm - Blunt Tip
Company
McNicoll Chirurgical Inc.
Model
202-450
Device description
Exchange K-Wire Ø2.4mm x 450mm - Blunt Tip
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253611000Falco Fusion SystemMcnicoll Surgical, Inc.2026-01-29OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540161800215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161800215075401618002157540161800215

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter2.4Millimeter
Guidewire Length450Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (833) 488-8688info@mcnicollsurgical.com

Regulatory Flags#

DUNS number
243338669
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540161800017Ø11mm Sacroiliac Falco Fusion Screw - L35mm111-0352026-03-27
07540161800024Ø11mm Sacroiliac Falco Fusion Screw - L40mm111-0402026-03-27
07540161800031Ø11mm Sacroiliac Falco Fusion Screw - L45mm111-0452026-03-27
07540161800048Ø11mm Sacroiliac Falco Fusion Screw - L50mm111-0502026-03-27
07540161800055Ø11mm Sacroiliac Falco Fusion Screw - L55mm111-0552026-03-27
07540161800062Ø11mm Sacroiliac Falco Fusion Screw - L60mm111-0602026-03-27
07540161800079Ø11mm Sacroiliac Falco Fusion Screw - L65mm111-0652026-03-27
07540161800086Ø11mm Sacroiliac Falco Fusion Screw - L70mm111-0702026-03-27
07540161800093Ø11mm Sacroiliac Falco Fusion Screw - L75mm111-0752026-03-27
07540161800109Ø13mm Sacroiliac Falco Fusion Screw - L35mm113-0352026-03-27
07540161800116Ø13mm Sacroiliac Falco Fusion Screw - L40mm113-0402026-03-27
07540161800123Ø13mm Sacroiliac Falco Fusion Screw - L45mm113-0452026-03-27
07540161800130Ø13mm Sacroiliac Falco Fusion Screw - L50mm113-0502026-03-27
07540161800147Ø13mm Sacroiliac Falco Fusion Screw - L55mm113-0552026-03-27
07540161800154Ø13mm Sacroiliac Falco Fusion Screw - L60mm113-0602026-03-27
07540161800161Ø13mm Sacroiliac Falco Fusion Screw - L65mm113-0652026-03-27
07540161800178Ø13mm Sacroiliac Falco Fusion Screw - L70mm113-0702026-03-27
07540161800185Ø13mm Sacroiliac Falco Fusion Screw - L75mm113-0752026-03-27
07540161800192K-Wire Ø2.4mm x 280mm - Trocar Tip201-2802026-03-27
07540161800208K-Wire Ø2.4mm x 280mm - Blunt Tip202-2802026-03-27

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