Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031680559

FEI Number

3031680559

Entity Name

McNicoll Surgical, Inc.

City/State/Country

Quebec City, CA

Establishment Address

702-1750 Ave de Vitre, Quebec City G1J 1Z6, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

McNicoll Surgical (Owner Number: 10095533)

Owner / Operator Contact Address

702-1750 Ave de Vitre, Quebec City, CA-QC G1J 1Z6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253611

PMA Number

N/A

All Registered Proprietary Names

Falco Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-03-25

Official Correspondent

Hugo Robichaud

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: wen.wang@willowglenfda.com Phone: (619) 8690249

Related Public Records

Same Entity

McNicoll Surgical

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
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031680559. Last updated year: 2026. Please use registration number 3031680559 when referencing this establishment in official correspondence.