Translace™ Spinal Tethering System

GUDID 00763000333409

TETHER 9010007014 0.4MM INSERT ASSEMBLY

MEDTRONIC SOFAMOR DANEK, INC.

Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable Surgical support tape, non-bioabsorbable
Primary Device ID00763000333409
NIH Device Record Key38936c1a-8f7e-431a-bdfa-94ebae6dd813
Commercial Distribution StatusIn Commercial Distribution
Brand NameTranslace™ Spinal Tethering System
Version Model Number9010007014
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100763000333409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWIBone fixation cerclage, sublaminar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-06
Device Publish Date2020-09-28

On-Brand Devices [Translace™ Spinal Tethering System]

00643169742949TRAY 8239100 TRANSLACE INSTRUMENTS
00643169726932TENSIONER 8239000 TENSIONER
00643169726925TETHER 8219500 TETHER
00643169726918CONNECTOR 8205300 5.5/6.0 CONNECTOR
00763000108397TETHER 8219500 TETHER
00763000108380CONNECTOR 8205300 CONNECTOR
00763000099701TRAY 8239100 TRANSLACE INSTRUMENTS
00763000333409TETHER 9010007014 0.4MM INSERT ASSEMBLY
00763000333393TETHER 9010007013 0.3MM INSERT ASSEMBLY
00763000333386TETHER 9010007012 0.2MM INSERT ASSEMBLY
00763000108403TENSIONER 8239000 TENSIONER

Trademark Results [Translace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRANSLACE
TRANSLACE
87469368 5612843 Live/Registered
Warsaw Orthopedic, Inc.
2017-05-31
TRANSLACE
TRANSLACE
86456468 not registered Dead/Abandoned
Warsaw Orthopedic, Inc.
2014-11-17
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