Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183671

FEI Number

2183671

Entity Name

COMPASS International Innovations, Inc.

City/State/Country

Rochester, MN, US

Establishment Address

1815 14TH ST. NW, SUITE A, Rochester, MN 55901, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

COMPASS INTERNATIONAL (Owner Number: 1318929)

Owner / Operator Contact Address

1815 14TH ST. NW, SUITE A, Rochester, MN 55901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K871046

PMA Number

N/A

All Registered Proprietary Names

COMPASS CT Stereotactic Adaptation Regulus Navigator/CYGNUS-PFS COMPASS Stereotactic Retractor Sys COMPASS Stereotactic Positioning Sy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-12-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2007-12-04
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2008-12-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-12-02

Official Correspondent

JON ROUSU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COMPASS INTERNATIONAL

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
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183671. Last updated year: 2026. Please use registration number 2183671 when referencing this establishment in official correspondence.