FDA.reportPublic FDA data

Stealth AXiS

Primary DI
00763000928933
Brand
Stealth AXiS
Company
MEDTRONIC NAVIGATION, INC.
Model
9736510
Device description
AXIS EM SPINE REF FRAME TRACKER 9736510
Published
2026-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00763000928933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000928933007630009289337630009289330763000928933

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
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000404871StealthStation™97359632026-05-23
00199150006427Stealth AXiS97365512026-04-24
00199150071586Stealth AXiS97367642026-04-19
00199150071609Stealth AXiS97367662026-04-19
00763000928896Stealth AXiS97365172026-04-11
00763000928902Stealth AXiS97365182026-04-11
00763000928919Stealth AXiS97365212026-04-10
00763000928926Stealth AXiS97365332026-04-10
00763000945947Stealth AXiS97365202026-04-10
00763000945954Stealth AXiS97365192026-04-10
00763000983840Stealth AXiS97366782026-04-11
00763000983864Stealth AXiS97366792026-04-11
00763000983888Stealth AXiS97366802026-04-11
00763000984441Stealth AXiS97364812026-04-10
00763000984458Stealth AXiS97364822026-04-10
00763000984465Stealth AXiS97364832026-04-10
00763000984472Stealth AXiS97364842026-04-10
00763000984489Stealth AXiS97364852026-04-10
00763000984496Stealth AXiS97364862026-04-10
00763000984502Stealth AXiS97365032026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422367RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422374RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422381RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422121RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422138RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422145RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422152RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422169RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422176RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422183RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422190RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422206RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422213RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422220RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422237RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422244RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422251RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
M711LS7810Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7820Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7830Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31