FDA.reportPublic FDA data

ENDOSKELETON® TAS

Primary DI
00191375040118
Brand
ENDOSKELETON® TAS
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2300-1319
Device description
Anterolateral Inserter, Large Footprint, 10-12mm
Published
2019-09-30
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
HWRDRIVER, PROSTHESIS
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111626000
K192054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111626000ENDOSKELETON(R) TASTitan Spine, LLC2011-09-09OVD
K192054000Endoskeleton TAS PlateTitan Spine, Inc.2019-08-29OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375040118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375040118001913750401181913750401180191375040118

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046202AVS PLStryker CorporationOVD2015-09-14
07613153046219AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046233AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationOVD2015-09-14
07613153046332AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14