FDA.reportPublic FDA data

TITANIUM TSRH® Spinal System

Primary DI
00673978137186
Brand
TITANIUM TSRH® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0494-008
Device description
TSR 5.5 VAS SPACER 6MM TI
Published
2015-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000991000MODIFICATION TO TSRH SPINAL SYSTEMMedtronic Sofamor Danek, Inc.2000-04-18MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978137186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978137186006739781371866739781371860673978137186

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
Device Size Text, specify0

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
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
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24