DYNALOK PLUS™ Spinal System

GUDID 00673978928807

SCREW 8430005 DY NON BREAK OFF NUT TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00673978928807
NIH Device Record Keyaa434a0c-84d7-41d5-9fbc-fbdc0f74549d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDYNALOK PLUS™ Spinal System
Version Model Number8430005
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978928807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00673978928807]

Moist Heat or Steam Sterilization


[00673978928807]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-19

On-Brand Devices [DYNALOK PLUS™ Spinal System]

00673978973036CONNECTOR 8436072C 6.35MM EXTENDED
00673978972978CONNECTOR 8436056C 6.35MM STRAIGHT
00673978950037SCREW 8430006 DY AUTO BREAK OFF NUT TI
00673978928807SCREW 8430005 DY NON BREAK OFF NUT TI
00721902973666CONNECTOR X0880455R 5.5 CLOSE RT OFFSET
00721902973659CONNECTOR X0880455L 5.5 CLOSE LT OFFSET

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