TSRH® Spinal System

GUDID 00613994360335

SCREW X0607081 5.5MAS DISTHR 6.0X55X10SS

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00613994360335
NIH Device Record Key7321a7bb-2c5a-4063-8627-905860a87590
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSRH® Spinal System
Version Model NumberX0607081
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994360335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

[00613994360335]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-16

On-Brand Devices [TSRH® Spinal System]

00613994888518SCREW X09103822 4.5X30 MPA LONG-POST
00613994888501SCREW X09103823 4.5X35 MPA LONG-POST
00613994888495SCREW X09103824 4.5X40 MPA LONG-POST
00613994888488SCREW X09103825 4.5X45 MPA LONG-POST
00613994888471SCREW X09103826 4.5X50 MPA LONG-POST
00613994888464SCREW X09103827 4.5X55 MPA LONG-POST
00613994888457SCREW X09103828 4.5X60 MPA LONG-POST
00613994888440SCREW X09103829 4.5X30 MPA SHORT-POST
00613994888433SCREW X09103830 4.5X35 MPA SHORT-POST
00613994888426SCREW X09103831 4.5X40 MPA SHORT-POST
00613994888419SCREW X09103832 4.5X45 MPA SHORT-POST
00613994888402SCREW X09103833 4.5X50 MPA SHORT-POST
00613994888396SCREW X09103834 4.5X55 MPA SHORT-POST
00613994888389SCREW X09103835 4.5X60 MPA SHORT-POST
00613994888358SCREW 83565359H TSRH OSTEOGRIP HA
00613994888341SCREW 83565309H TSRH OSTEOGRIP HA
00613994888334SCREW 83565259H TSRH OSTEOGRIP HA
00613994888327SCREW 83565209H TSRH OSTEOGRIP HA
00613994888310SCREW 83555609H TSRH OSTEOGRIP HA
00613994888303SCREW 83555559H TSRH OSTEOGRIP HA
00613994888297SCREW 83555509H TSRH OSTEOGRIP HA
00613994888280SCREW 83555459H TSRH OSTEOGRIP HA
00613994888273SCREW 83555409H TSRH OSTEOGRIP HA
00613994888266SCREW 83555359H TSRH OSTEOGRIP HA
00613994888259SCREW 83555309H TSRH OSTEOGRIP HA
00613994888242SCREW 83555259H TSRH OSTEOGRIP HA
00613994888235SCREW 83555209H TSRH OSTEOGRIP HA
00613994888228SCREW 83545609H TSRH OSTEOGRIP HA
00613994888211SCREW 83545559H TSRH OSTEOGRIP HA
00613994888204SCREW 83545509H TSRH OSTEOGRIP HA
00613994888198SCREW 83545459H TSRH OSTEOGRIP HA
00613994888181SCREW 83545409H TSRH OSTEOGRIP HA
00613994888174SCREW 83545359H TSRH OSTEOGRIP HA
00613994888167SCREW 83545309H TSRH OSTEOGRIP HA
00613994888150SCREW 83545259H TSRH OSTEOGRIP HA
00613994888143SCREW 83545209H TSRH OSTEOGRIP HA
00613994888136SCREW 83565409H TSRH OSTEOGRIP HA
00613994888129SCREW 83585609H TSRH OSTEOGRIP HA
00613994888112SCREW 83585559H TSRH OSTEOGRIP HA
00613994888105SCREW 83585509H TSRH OSTEOGRIP HA
00613994888099SCREW 83585459H TSRH OSTEOGRIP HA
00613994888082SCREW 83585409H TSRH OSTEOGRIP HA
00613994888075SCREW 83585359H TSRH OSTEOGRIP HA
00613994888068SCREW 83585309H TSRH OSTEOGRIP HA
00613994888051SCREW 83585259H TSRH OSTEOGRIP HA
00613994888044SCREW 83585209H TSRH OSTEOGRIP HA
00613994888037SCREW 83575609H TSRH OSTEOGRIP HA
00613994888020SCREW 83575559H TSRH OSTEOGRIP HA
00613994888013SCREW 83575509H TSRH OSTEOGRIP HA
00613994888006SCREW 83575459H TSRH OSTEOGRIP HA

Trademark Results [TSRH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TSRH
TSRH
74164314 1694200 Live/Registered
TEXAS SCOTTISH RITE HOSPITAL FOR CRIPPLED CHILDREN
1991-05-06
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