Prestige LP™ Cervical Disc System with Streamlined Instruments

GUDID 00763000200633

TRAY 6978021 8MM STREAMLINED INSTRUMENTS

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00763000200633
NIH Device Record Key7dc1d3e0-be89-4047-b2e7-6a4d8eebe31e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrestige LP™ Cervical Disc System with Streamlined Instruments
Version Model Number6978021
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000200633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2019-07-06

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000242510 - MSB Reusable Instruments2025-05-19 GRAFT DELIVERY 6061020 LOADING PLATFORM
00763000873332 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-05-19 IMPLANT G7736746 MP LORDO 6MMX17MMX14MM
00763000873349 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-05-19 IMPLANT G7736526 MP LORDO 6MMX15MMX12MM
00763000873561 - LOW PROFILE CROSSLINK® System2025-05-19 19X10 CROSSLINK 6.35 TI STER
00763000873578 - LOW PROFILE CROSSLINK® System2025-05-19 22X10 CROSSLINK 6.35 TI STER
00763000873585 - LOW PROFILE CROSSLINK® System2025-05-19 25X10 CROSSLINK 6.35 TI STER
00763000878061 - CD HORIZON® Spinal System2025-05-19 RASP 6630914 PARALLEL 5MMX15MMX12MM
00763000885885 - Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology2025-05-19 NANO SPACER 5346-1212-N TCS 6 DG SM 12MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.