FDA.reportPublic FDA data

Anteralign Spinal System with Titan nanoLock Surface technology

Primary DI
00763000147730
Brand
Anteralign Spinal System with Titan nanoLock Surface technology
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
46822612
Device description
TRIAL 46822612 LG 6DG 32X25X12MM
Published
2022-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE
MAXIntervertebral fusion device with bone graft, lumbar
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214010000
K221180000
K222383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214010000Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA2022-04-12MAX
K221180000Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.2022-05-25OLO
K222383000Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) EditionMedtronic Sofamor Danek USA, Inc.2022-09-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000147730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000147730007630001477307630001477300763000147730

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150075034Medtronic Reusable InstrumentsEX02260202026-07-10
00199150081882Medtronic Reusable InstrumentsX04260012026-07-10
00199150081899Medtronic Reusable InstrumentsX04260052026-07-10
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28

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