FDA.reportPublic FDA data

TRANSLACE™ Spinal Tethering System

Primary DI
00763000881702
Brand
TRANSLACE™ Spinal Tethering System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8219500
Device description
TETHER 8219500 TETHER
Published
2026-02-05
Public version status
New
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
OWIBone fixation cerclage, sublaminar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWIBone Fixation Cerclage, SublaminarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163181000TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.2017-05-16OWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000881702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000881702007630008817027630008817020763000881702

GMDN Terms#

Term, Definition table
TermDefinition
Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169190382CLYDESDALE PTC™ Spinal System49268552016-04-17
00643169190399CLYDESDALE PTC™ Spinal System49268502016-04-17
00643169190405CLYDESDALE PTC™ Spinal System49268452016-04-18
00643169190412CLYDESDALE PTC™ Spinal System49268402016-04-17
00643169190429CLYDESDALE PTC™ Spinal System49266602016-04-17
00643169190436CLYDESDALE PTC™ Spinal System49266552016-04-17
00643169190443CLYDESDALE PTC™ Spinal System49266502016-04-17
00643169190450CLYDESDALE PTC™ Spinal System49266452016-04-18
00643169190467CLYDESDALE PTC™ Spinal System49266402016-04-18
00643169190481CLYDESDALE PTC™ Spinal System49264552016-04-18
00643169190504CLYDESDALE PTC™ Spinal System49868602016-04-17
00643169190559CLYDESDALE PTC™ Spinal System49866602016-04-17
00643169190566CLYDESDALE PTC™ Spinal System49866552016-04-17
00643169190573CLYDESDALE PTC™ Spinal System49866502016-04-17
00643169190580CLYDESDALE PTC™ Spinal System49866452016-04-17
00643169190597CLYDESDALE PTC™ Spinal System49866402016-04-17
00643169190603CLYDESDALE PTC™ Spinal System49864602016-04-17
00643169190610CLYDESDALE PTC™ Spinal System49864552016-04-18
00643169190634CLYDESDALE PTC™ Spinal System49864452016-04-17
00643169190658CLYDESDALE PTC™ Spinal System49862602016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
00190376696140InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376696157InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721699InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721705InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721712InvictusALPHATEC SPINE, INC.OWI2026-04-09
00763000881696TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-02-05
00840085278518ALTAAstura MedicalOWI2026-02-03
00840085277603ALTAAstura MedicalOWI2026-02-02
00840085278051ALTAAstura MedicalOWI2026-02-02
00840085278068ALTAAstura MedicalOWI2026-02-02
10888857581852NILE™ Alternative Fixation SystemVB Spine LLCOWI2025-03-21
00887517721518VersaTieNuvasive, Inc.OWI2024-11-27
00763000675035TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2024-11-04
00193982506216HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506223HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506230HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506247HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506254HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506261HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506278HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506285HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506292HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506445HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506452HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506469HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506476HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506490HILINEGLOBUS MEDICAL, INC.OWI2024-07-22