Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010009632

FEI Number

3010009632

Entity Name

MULTISOURCE MANUFACTURING LLC

City/State/Country

Longmont, CO, US

Establishment Address

1530 Vista View Drive, Unit B, Longmont, CO 80504, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MULTISOURCE MANUFACTURING LLC (Owner Number: 9055838)

Owner / Operator Contact Address

6690 Sunwood Dr. NW, --, Ramsey, MN 55303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STEALTHSTATION CRANIAL REFERENCE FRAME POINTER STEALTHSTATION HOUSING, MC BACK MANIFOLD DOOR MOUNTING CHAMBER MAGNET BUBBLE DETECT DOOR Envision 3D Image Guidance System INTERCHANGEABLE PRF STEALTHSTATION AXIEM POWERED - ELECTRIC PERCUSSOR 9736520 AXIS 3DFL FLAT C-ARM ADAPTER 9736766 ADAPTER KIT O ARM CONTROLLER STEALTHSTATION DILATOR Flex ENT Floor Stand ENCLOSING HOUSING SPACER TRACKERS FRAMES PERISTALTIC PUMP MOUNT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2012-11-13
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-12
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-03-09
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-03-09
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-12
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-12-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-05-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-10-12
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-12
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-01-11
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-12
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2012-12-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-07
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2016-10-12
JOX	Analyzer, Heparin, Automated	Hematology	Class 2	864.5680	2013-01-11
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-12
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-10-12
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-08-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-12-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-12-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-10-12
GKN	Timer, Clot, Automated	Hematology	Class 2	864.5400	2013-01-11
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-12-13
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2013-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MULTISOURCE MANUFACTURING LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011604145	MULTISOURCE MFG. LLC	Fridley, MN, US

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

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 3010009632. Last updated year: 2026. Please use registration number 3010009632 when referencing this establishment in official correspondence.