FDA.reportPublic FDA data

Falco Fusion System Surgical Instruments Tray (Full)

Primary DI
07540161800451
Brand
Falco Fusion System Surgical Instruments Tray (Full)
Company
McNicoll Chirurgical Inc.
Model
450-001
Device description
Reusable surgical instrument tray containing instruments used with the Falco Fusion System for sacroiliac joint fusion procedures.
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

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
07540161800451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161800451075401618004517540161800451

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

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
Serial number
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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