CD Horizon Modulex Spinal System

GUDID 00763000352028

TAP RBT071575 RG SABER 7.5 AWL-TIP SHORT

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable
Primary Device ID00763000352028
NIH Device Record Keye18c6a6e-60e9-4fb8-8be6-ac7da00e06c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD Horizon Modulex Spinal System
Version Model NumberRBT071575
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 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
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
GS100763000352028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


[00763000352028]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-03
Device Publish Date2021-12-25

On-Brand Devices [CD Horizon Modulex Spinal System]

00763000516208LID RBT090014 MIDLINE ARM GUIDE CADDY
00763000516192CADDY RBT090013 MIDLINE ARM GUIDE
00763000352028TAP RBT071575 RG SABER 7.5 AWL-TIP SHORT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.