ZEPHIR® Anterior Cervical System

GUDID 00721902610684

SCREW 8792911 VA SELF DRILLING 4.0X11MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00721902610684
NIH Device Record Key595fc8c8-579f-4954-8883-319452d9faa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEPHIR® Anterior Cervical System
Version Model Number8792911
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
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 Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter
Length11 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902610684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

Moist Heat or Steam Sterilization

[00721902610684]

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 System]

00613994544728SCREW X0508083 ZEP SCR SD 3.5X16
00613994544711SCREW X0508082 ZEP SCR SD 4.0X16
00613994544704SCREW X0508081 ZEP SCR SD 4.0X14
00613994265050SCREW X0706213 ZEP-SELF DRILL-D4.5-L15MM
00613994265043SCREW X0706214 ZEP-SELF DRILL-D4.5-L17MM
00613994265036PLATE X0706215 ZEP-WIDE-25MM
00613994265029PLATE X0706216 ZEP-WIDE-27.5MM
00613994265012PLATE X0706217 ZEP-WIDE-30MM
00613994265005PLATE X0706218 ZEP-WIDE-32.5MM
00613994264992PLATE X0706219 ZEP-WIDE-35MM
00613994264985PLATE X0706220 ZEP-WIDE-37.5MM
00613994264978PLATE X0706221 ZEP-WIDE-40MM
00613994264961PLATE X0706222 ZEP-WIDE-42.5MM
00613994264954SCREW X0706212 ZEP-SELF DRILL-D4.5-L13MM
00613994264947SCREW X0706211 ZEP-SELF DRILL-D4.0-L18MM
00613994264930SCREW X0706210 ZEP-SELF DRILL-D4.0-L17MM
00613994264923SCREW X0706209 ZEP-SELF DRILL-D4.0-L16MM
00613994264916SCREW X0706208 ZEP-SELF DRILL-D4.0-L15MM
00613994264909SCREW X0706207 ZEP-SELF DRILL-D4.0-L14MM
00613994264893SCREW X0706206 ZEP-SELF DRILL-D4.0-L13MM
00613994264886SCREW X0706205 ZEP-SELF DRILL-D4.0-L12MM
00613994264879SCREW X0706204 ZEP-SELF DRILL-D4.0-L11MM
00613994264862SCREW X0706203 ZEP-SELF DRILL-D4.0-L10MM
00613994264855PLATE X0706242 ZEP-WIDE-95MM
00613994264848PLATE X0706241 ZEP-WIDE-90MM
00613994264831PLATE X0706240 ZEP-WIDE-87.5MM
00613994264824PLATE X0706239 ZEP-WIDE-85MM
00613994264817PLATE X0706238 ZEP-WIDE-82.5MM
00613994264800PLATE X0706237 ZEP-WIDE-80MM
00613994264794PLATE X0706236 ZEP-WIDE-77.5MM
00613994264787PLATE X0706235 ZEP-WIDE-75MM
00613994264770PLATE X0706234 ZEP-WIDE-72.5MM
00613994264763PLATE X0706233 ZEP-WIDE-70MM
00613994264756PLATE X0706232 ZEP-WIDE-67.5MM
00613994264749PLATE X0706231 ZEP-WIDE-65MM
00613994264732PLATE X0706230 ZEP-WIDE-62.5MM
00613994264725PLATE X0706229 ZEP-WIDE-60MM
00613994264718PLATE X0706228 ZEP-WIDE-57.5MM
00613994264701PLATE X0706227 ZEP-WIDE-55MM
00613994264695PLATE X0706226 ZEP-WIDE-52.5MM
00613994264688PLATE X0706225 ZEP-WIDE-50MM
00613994264671PLATE X0706224 ZEP-WIDE-47.5MM
00613994264664PLATE X0706223 ZEP-WIDE-45MM
00681490540957SCREW 8792717 VASD CNCLLS 4.0X17MM
00681490540940SCREW 8792715 VAST CNCLLS 4.0X15MM
00681490540933SCREW 8792713 VAST CNCLLS 4.0X13MM
00681490540926PLATE 8799170 ZEPHIR 70MM TI
00681490540919PLATE 8799167 ZEPHIR 67.5MM TI
00681490540902PLATE 8799165 ZEPHIR 65MM TI
00681490540896PLATE 8799162 ZEPHIR 62.5MM TI

Trademark Results [ZEPHIR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZEPHIR
ZEPHIR
79064464 not registered Dead/Abandoned
ZEPHIR S.P.A.
2008-10-31
ZEPHIR
ZEPHIR
78275530 not registered Dead/Abandoned
SDGI Holdings, Inc.
2003-07-17
ZEPHIR
ZEPHIR
78030148 2942820 Live/Registered
WARSAW ORTHOPEDIC, INC.
2000-10-11
ZEPHIR
ZEPHIR
77857486 3888715 Live/Registered
ZEPHIR S.p.A.
2009-10-26
ZEPHIR
ZEPHIR
76651187 3361188 Live/Registered
QinetiQ Limited
2005-11-30
ZEPHIR
ZEPHIR
75817363 not registered Dead/Abandoned
SDGI Holdings, Inc.
1999-10-07
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