CD HORIZON Spinal System

GUDID 00643169576827

TAP 6641085 8.5MM CANNULATED DUAL LEAD

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, reusable
Primary Device ID00643169576827
NIH Device Record Keyddeaf741-ec9f-4a15-bef5-2853fd0dc67e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD HORIZON Spinal System
Version Model Number6641085
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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 Dimensions

Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169576827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169576827]

Moist Heat or Steam Sterilization

[00643169576827]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-04-16

On-Brand Devices [CD HORIZON Spinal System]

00643169623682ROTATION ROD 653101500 500X5.5MM TI AL S
00643169623675ROTATION ROD 653101480 480X5.5MM TI AL S
00643169623668ROTATION ROD 653101460 460X5.5MM TI AL S
00643169623651ROTATION ROD 653101440 440X5.5MM TI AL S
00643169623644ROTATION ROD 653101420 420X5.5MM TI AL S
00643169623637ROTATION ROD 653101400 400X5.5MM TI AL S
00643169623620ROTATION ROD 653101380 380X5.5MM TI AL S
00643169623613ROTATION ROD 653101360 360X5.5MM TI AL S
00643169623606ROTATION ROD 653101340 340X5.5MM TI AL S
00643169623590ROTATION ROD 653101320 320X5.5MM TI AL S
00643169623583ROTATION ROD 653101300 300X5.5MM TI AL S
00643169623576ROTATION ROD 653101290 290X5.5MM TI AL S
00643169623569ROTATION ROD 653101280 280X5.5MM TI AL S
00643169623552ROTATION ROD 653101270 270X5.5MM TI AL S
00643169623545ROTATION ROD 653101260 260X5.5MM TI AL S
00643169623538ROTATION ROD 653101250 250X5.5MM TI AL S
00643169623521ROTATION ROD 653101240 240X5.5MM TI AL S
00643169623514ROTATION ROD 653101230 230X5.5MM TI AL S
00643169623507ROTATION ROD 653101220 220X5.5MM TI AL S
00643169623491ROTATION ROD 653101210 210X5.5MM TI AL S
00643169623484ROTATION ROD 653101200 200X5.5MM TI AL S
00643169623477ROTATION ROD 653101190 190X5.5MM TI AL S
00643169623460ROTATION ROD 653101180 180X5.5MM TI AL S
00643169623453ROTATION ROD 653101170 170X5.5MM TI AL S
00643169623446ROTATION ROD 653101160 160X5.5MM TI AL S
00643169623439ROTATION ROD 653101150 150X5.5MM TI AL S
00643169623422ROTATION ROD 653001500 500 X 5.5MM TI AL
00643169623415ROTATION ROD 653001480 480 X 5.5MM TI AL
00643169623408ROTATION ROD 653001460 460 X 5.5MM TI AL
00643169623392ROTATION ROD 653001440 440 X 5.5MM TI AL
00643169623385ROTATION ROD 653001420 420 X 5.5MM TI AL
00643169623378ROTATION ROD 653001400 400 X 5.5MM TI AL
00643169623361ROTATION ROD 653001380 380 X 5.5MM TI AL
00643169623354ROTATION ROD 653001360 360 X 5.5MM TI AL
00643169623347ROTATION ROD 653001340 340 X 5.5MM TI AL
00643169623330ROTATION ROD 653001320 320 X 5.5MM TI AL
00643169623323ROTATION ROD 653001300 300 X 5.5MM TI AL
00643169623316ROTATION ROD 653001290 290 X 5.5MM TI AL
00643169623309ROTATION ROD 653001280 280 X 5.5MM TI AL
00643169623293ROTATION ROD 653001270 270 X 5.5MM TI AL
00643169623286ROTATION ROD 653001260 260 X 5.5MM TI AL
00643169623279ROTATION ROD 653001250 250 X 5.5MM TI AL
00643169623262ROTATION ROD 653001240 240 X 5.5MM TI AL
00643169623255ROTATION ROD 653001230 230 X 5.5MM TI AL
00643169623248ROTATION ROD 653001220 220 X 5.5MM TI AL
00643169623231ROTATION ROD 653001210 210 X 5.5MM TI AL
00643169623224ROTATION ROD 653001200 200 X 5.5MM TI AL
00643169623217ROTATION ROD 653001190 190 X 5.5MM TI AL
00643169623200ROTATION ROD 653001180 180 X 5.5MM TI AL
00643169623194ROTATION ROD 653001170 170 X 5.5MM TI AL
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