Medtronic HV-R® Fenestrated Screw Cement

GUDID 00643169715127

CEMENT 7480724T FENESTRATED SCRW PMMA US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated
Primary Device ID00643169715127
NIH Device Record Key2d2191c4-3d6f-43af-b16f-597d92e5f64a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedtronic HV-R® Fenestrated Screw Cement
Version Model Number7480724T
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169715127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-09

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000855215 - n/a2025-06-06 INSTRUMENT 6248864 8X16X14 TRIAL
00763000889159 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3120315 4.0 X 15 SELF TAP VAR
00763000889166 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3120314 4.0 X 14 SELF TAP VAR
00763000889173 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3120313 4.0 X 13 SELF TAP VAR
00763000889227 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3125313 4.5 X 13 SELF TAP VAR
00763000889319 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3120214 4.0 X 14 SELF TAP FIX
00763000889425 - ATLANTIS® Anterior Cervical Plate System2025-06-06 SCREW 3120514 4.0 X 14 SELF DRILL VAR

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