FDA.reportPublic FDA data

Stealth AXiS

Primary DI
00763000995270
Brand
Stealth AXiS
Company
MEDTRONIC NAVIGATION, INC.
Model
9736676
Device description
XIS SPINE STBL CLAMP LINK 9736676 LONG
Published
2026-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253381000Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.2026-02-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000995270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000995270007630009952707630009952700763000995270

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150071968Stealth AXiS Leica Kit97367562026-09-25
00199150071975Stealth AXiS Kinevo 900 Kit97367572026-09-25
00199150071982Stealth AXiS Pentero 900 Kit97367582026-09-25
00199150054404ZEISS TIVATO 70097367222026-09-21
00199150054442ZEISS PENTERO 800S97367242026-09-21
00199150067633Stealth AXiS Advanced Spine Referencing Kit97366922026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SS97366962026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SS97366972026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SS97366982026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SS97366992026-09-06
00763000384234N/A97361462021-08-13
00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter Kit97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter Kit97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm Tracker97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm Tracker97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless Steel97367002026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT97366952026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer Tracker97365172026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification Device97365182026-08-15
00763000995195Stealth AXiS97366722026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres LBrainlab SEOLO2026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
04056481147693Quip Instrument Adapter Clamp Size SBrainlab SEOLO2026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size MBrainlab SEOLO2026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size LBrainlab SEOLO2026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
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04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
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00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26