IB3D™ PL Spinal System

GUDID 00763000883492

TRAY A24100100 IB3D PL TRAY

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable
Primary Device ID00763000883492
NIH Device Record Keyc2217b45-478f-4f8b-8b09-5bad2f97db48
Commercial Distribution StatusIn Commercial Distribution
Brand NameIB3D™ PL Spinal System
Version Model NumberA24100100
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 Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000883492 [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

[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000873226 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 PLATE G7731505 DIVERGENCE MINI 15.5MM
00763000873233 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 PLATE G7731506 DIVERGENCE MINI 16.5MM
00763000873325 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 IMPLANT G7736527 MP LORDO 7MMX15MMX12MM
00763000885755 - Endoskeleton™ TT Interbody System with Titan nanoLOCK™ Surface Technology2025-06-24 NANO SPACER 4114-3509-N TT 4 DG XLG 9MM
00763000889135 - ATLANTIS® Anterior Cervical Plate System2025-06-24 SCREW 3120317 4.0 X 17 SELF TAP VAR
00763000889470 - ATLANTIS® Anterior Cervical Plate System2025-06-24 SCREW 3125513 4.5 X 13 SELF DRILL VAR
00763000873608 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 SCREW PK2 G7733513 MINIP S-D 3.5MM X13MM
00199150000517 - Medtronic Reusable Instruments2025-06-23 INSERTER X468001500 CC 15DEG UP SHORT

Trademark Results [IB3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IB3D
IB3D
98258478 not registered Live/Pending
Medicrea International
2023-11-07

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