FDA.reportPublic FDA data

ENDOSKELETON® TA nanoLOCK® Surface Technology

Primary DI
00191375012115
Brand
ENDOSKELETON® TA nanoLOCK® Surface Technology
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2107-0117-N
Device description
Interbody Fusion Device 7 Degree Standard 17mm
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
MPQCONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The CounterPathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080615000
K141953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080615000ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)Titan Spine, LLC2008-06-17MAX
K141953000ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLTitan Spine, LLC2014-10-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375012115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375012115001913750121151913750121150191375012115

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth21Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height17Millimeter
Width32Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(262)242-7801productinfo@titanspine.com
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy System43612582026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy System43612252026-10-11
00763000874209MSB SHILLA Growth Guidance System76745002026-10-11
00763000885502MSB Reusable Instruments7080921D2026-10-11
00824846010722Medtronic Reusable InstrumentsX07260022026-10-09
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900817EARP, 22X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900824EARP, 22X40X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900831EARP, 22X45X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900848EARP, 22X45X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900855EARP, 22X45X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900862EARP, 22X45X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900879EARP, 22X45X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901265EARP, 22X50X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901272EARP, 22X50X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901289EARP, 22X50X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901296EARP, 22X50X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901302EARP, 22X50X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10