FDA.reportPublic FDA data

Anteralign Spinal System with Titan nanoLock Surface technology

Primary DI
00763000198343
Brand
Anteralign Spinal System with Titan nanoLock Surface technology
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
46511210
Device description
SPACER 46511210 MD TI 12DG 37X29X10MM
Published
2022-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214010000Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA2022-04-12MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000198343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000198343007630001983437630001983430763000198343

GMDN Terms#

Term, Definition table
TermDefinition
Spinal dynamic-stabilization systemA sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Lot or batch
true

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00824846003199Medtronic Reusable InstrumentsX55981452026-07-26
00824846003205Medtronic Reusable InstrumentsX55981462026-07-26
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
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00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19

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