FDA.reportPublic FDA data

TRANSLACE™ Spinal Tethering System

Primary DI
00643169742949
Brand
TRANSLACE™ Spinal Tethering System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8239100
Device description
TRAY 8239100 TRANSLACE INSTRUMENTS
Published
2017-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00643169742949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169742949006431697429496431697429490643169742949

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

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
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

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
00763000881702TRANSLACE™ 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