Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005718816

FEI Number

3005718816

Entity Name

Materialise USA, LLC.

City/State/Country

Plymouth, MI, US

Establishment Address

44650 Helm Court, Plymouth, MI 48170, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MATERIALISE N.V. (Owner Number: 9029485)

Owner / Operator Contact Address

Technologielaan 15, --, Leuven, BE-NOTA 3001, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172054

PMA Number

N/A

All Registered Proprietary Names

SurgiCase CMF Guide ProPlan CMF Guide Lima Personalized Surgical Instruments TruMatch Personalized Solutions Shoulder Guide SurgiCase Planner TruMatch Personalized Solutions Shoulder System Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System Materialise Glenoid Positioning System Match Point System guides Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner SurgiCase Guide SurgiCase Connect SurgiCase Orthopaedics System Materialise TKA Guide System Materialise Knee Guide System Signature Guides Lima Personalized Surgical Instruments SurgiCase Knee Planner Materialise SurgiCase Knee Planner Materialise TKA Guides Materialise Knee Platform Zimmer Patient Specific Instruments Planner Materialise TKA Guides and Models Materialise Knee Guides Materialise Knee Planner Signature Planner BKS Total PSI Materialise TKA Guide Planner Zimmer Biomet Patient Specific Instruments Materialise SurgiCase Knee Module Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Corin Optimized Positioning System (OPS) Femoral Materialise Shoulder Planner Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System Match Point System guides SurgiCase Shoulder Planner Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Planner Materialise SurgiCase Knee Planner Materialise TKA Guides Lima PSI Materialise Knee Guides Materialise TKA Guide planner Materialise SurgiCase Knee Module Materialise Knee Guide System Materialise Knee Planner Materialise Knee Guide planner SurgiCase Knee Planner Materialise Knee Platform Materialise TKA Guide System Materialise PKA Guides Materialise PKA Guide System Zimmer Patient Specific Instruments Signature Guides SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Planner Signature Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner SignatureTM Planner SignatureTM Guide SignatureTM Personalized Patient Care System SurgiCase Planner Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System Match Point System guides Materialise Shoulder Planner Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise Glenoid Positioning System TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System Materialise Shoulder System Materialise SurgiCase Planner Materialise Shoulder Guide and Models Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System guides TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System SurgiCase Shoulder Planner Materialise Shoulder Planner Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Planner Materialise Shoulder System Match Point System Signature Personalized Patient Care System Signature Planner Signature Guide TruMatch Personalized Solutions Shoulder Guide Materialise Glenoid Positioning System Lima Personalized Surgical Instruments Materialise Shoulder Planner Match Point System Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner Match Point System guides Materialise Shoulder Guide and Models AtlasPlan Shoulder System Materialise SurgiCase Planner Materialise Shoulder System SurgiCase Planner Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides ProPlan CMF Models CMF Titanium Guides CMF Plastic Models Materialise TKA Guide System Materialise TKA Guides SurgiCase Knee Planner Materialise SurgiCase Knee Module Materialise Knee Planner Materialise Knee Guides Materialise Knee Guide planner Materialise Knee Platform Bespoke PSI Materialise Knee Guide System Materialise TKA Guide planner Bespoke Patient Specific Instruments Materialise SurgiCase Knee Planner Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Signature Personalized Patient Care System Signature Planner Signature Guide Materialise Shoulder Guide and Models TruMatch Personalized Solutions Shoulder Guide Materialise SurgiCase Planner Match Point System Match Point System guides Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Materialise Shoulder Planner Materialise Glenoid Positioning System AtlasPlan Shoulder System Materialise Shoulder System SurgiCase Shoulder Planner SurgiCase Planner TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Titanium 3D Printed Implant System SurgiCase Shoulder Planner Lima Personalized Surgical Instruments Match Point System Materialise Glenoid Positioning System guides Materialise Shoulder Planner Match Point System guides Materialise SurgiCase Planner Materialise Glenoid Positioning System Signature Personalized Patient Care System Signature Planner Signature Guide TruMatch CMF Titanium 3D Printed Implant System TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants MatchPoint System TM Guides SurgiCase Connect MatchPoint System TM SurgiCase Orthopaedics SurgiCase Guide SurgiCase Connect Phits BKS Total PSI Signature Guides Materialise TKA Guide System Materialise TKA Guides and Models Zimmer Biomet Patient Specific Instruments Materialise TKA Guide Planner SurgiCase Knee Planner Materialise Knee Guide System Zimmer Patient Specific Instruments Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise Knee Planner Lima Personalized Surgical Instruments Materialise Knee Platform Signature Planner SurgiCase Connect SurgiCase Guide SurgiCase Orthopaedics Mimics inPrint ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides Signature Guides Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise SurgiCase Knee Planner BKS Total PSI Lima Personalized Surgical Instruments Materialise TKA Guides and Models SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Signature Planner Materialise TKA Guide System Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Materialise Knee Guide System Materialise TKA Guide Planner Materialise Knee Platform Materialise Knee Planner Materialise PKA Guides Materialise PKA Models SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Materialise PKA Guide System Materialise Shoulder System Materialise Shoulder Guide and Models Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System AtlasPlan Shoulder System TruMatch Personalized Solutions Shoulder Guide Match Point System guides Lima Personalized Surgical Instruments SurgiCase Shoulder Planner Materialise Glenoid Positioning System guides SurgiCase Planner Materialise Glenoid Positioning System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System SurgiCase Models ProPlan CMF (Orthognathic Splints) ProPlan CMF Models SurgiCase CMF Models HeartPrint AnatomyPrint Match Point System Materialise Shoulder Planner Lima Personalized Surgical Instruments Materialise SurgiCase Planner Match Point System guides Materialise Glenoid Positioning System TruMatch Personalized Solutions Shoulder Guide SurgiCase Shoulder Planner SurgiCase Planner TruMatch Personalized Solutions Shoulder System Materialise Glenoid Positioning System guides

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-04-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-07-17
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2017-02-07
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-09-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2025-09-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-09-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-09-25
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2012-01-24
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-01-24
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2018-09-19
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-09-19
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-09-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-09-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-06-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-11-28
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-11-28
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-11-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2016-11-28
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-07-13
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2018-07-13
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-12-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-27
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-07-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-07-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-07-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-07-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-07-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-07-06
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2012-07-06
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-09-15
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2022-09-15
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-12-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-03
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-02-09
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-02-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-02-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-02-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-11-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-11-30
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-11-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-02-26
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2025-02-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-08-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-08-19
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2015-08-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-08-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-06-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-06-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-06-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-06-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-26
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2011-05-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-05-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-05-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-05-26
PHS	Oral Airway Assist	Anesthesiology	Class 1	868.5110	2023-05-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-05-23
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-05-23
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-08-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-07-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-04-30
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-04-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-04-30
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-04-30
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-04-30
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-11-07
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2014-04-23
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2019-01-22
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2026-03-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-03-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2026-03-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2026-03-03
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2012-08-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-03-26
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	Class 2	882.4310	2026-01-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-07-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-07-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-07-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2022-07-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2020-12-10
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-12-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-18
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-06-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-04-11
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-04-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2012-04-11
HWT	Template	Orthopedic	Class 1	888.4800	2003-12-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MATERIALISE N.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026963399	Materialise S.A.	Bielany Wroclawskie Dolnoslaskie, PL
3006543248	Materialise Motion N.V.	Paal Limburg, BE
3003998208	MATERIALISE N.V.	LEUVEN Vlaams Brabant, BE
3009555440	Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, UA
3011724582	Materialise Colombia S.A.S	Medellin Antioquia, CO

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
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28

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 3005718816. Last updated year: 2026. Please use registration number 3005718816 when referencing this establishment in official correspondence.