ZEPHIR Anterior Cervical Plate System

GUDID 00885074002460

ZEP SCR-ST-4.0X15-SQDRV

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00885074002460
NIH Device Record Keyda923549-bb3b-42ba-a9fc-3896729736e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEPHIR Anterior Cervical Plate System
Version Model NumberX1103415
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

Device Dimensions

Length15 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074002460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885074002460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-19

On-Brand Devices [ZEPHIR Anterior Cervical Plate System]

00885074002477ZEP SCR-ST-4.0X17-SQDRV
00885074002460ZEP SCR-ST-4.0X15-SQDRV
00885074002453ZEP SCR-ST-4.0X13-SQDRV
00885074002446ZEP SCR-ST-4.0X11-SQDRV
00885074002439ZEP SCR-ST-3.5X17-SQDRV
00885074002422ZEP SCR-ST-3.5X15-SQDRV
00885074002415ZEP SCR-ST-3.5X13-SQDRV
00885074002392ZEP SCR-ST-3.5X11-SQDRV

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