CD Horizon® Ballast™ Spinal System

GUDID 00643169523852

TRAY 2950006 NAVIGATION INSTRUMENTS

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00643169523852
NIH Device Record Keyceb597e9-91ad-4beb-a7f3-76411bf2e38d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD Horizon® Ballast™ Spinal System
Version Model Number2950006
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
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
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100643169523852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


[00643169523852]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-09
Device Publish Date2017-12-15

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000856502 - Pyramesh® Implant System2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM
00763000856519 - Pyramesh® Implant System2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM
00763000856526 - Pyramesh® Implant System2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM
00763000856533 - Pyramesh® Implant System2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM
00763000856557 - Pyramesh® Implant System2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM

Trademark Results [CD Horizon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD HORIZON
CD HORIZON
75079759 2108361 Live/Registered
WARSAW ORTHOPEDIC, INC.
1996-03-28

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