PEEK PREVAIL™ Cervical Interbody Device

GUDID 00613994645999

SPACER 9010000037 PRV PK 16X12X7

MEDTRONIC SOFAMOR DANEK, INC.

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Primary Device ID00613994645999
NIH Device Record Key78618189-895a-4736-a746-6b618de80c6c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK PREVAIL™ Cervical Interbody Device
Version Model Number9010000037
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100613994645999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

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 Date2015-09-01

On-Brand Devices [PEEK PREVAIL™ Cervical Interbody Device]

00613994853264HANDLE 1204477 SCREW GUIDE
00613994753922SCREW GUIDE 1225555
00613994646019SPACER 9010000039 PRV PK 16X12X9
00613994646002SPACER 9010000038 PRV PK 16X12X8
00613994645999SPACER 9010000037 PRV PK 16X12X7
00613994645982SPACER 9010000036 PRV PK 16X12X6
00613994645975SPACER 9010000035 PRV PK 16X12X5
00613994645777TRASP 9010000049 CERVICAL 9X16X12
00613994645760TRASP 9010000048 CERVICAL 8X16X12
00613994645753TRASP 9010000047 CERVICAL 7X16X12
00613994645746TRASP 9010000046 CERVICAL 6X16X12
00613994645739TRASP 9010000045 CERVICAL 5X16X12
00613994502124IMPLANT 4210964 STANDALONE 16 X 14 X 9MM
00613994502117IMPLANT 4210864 STANDALONE 16 X 14 X 8MM
00613994502100IMPLANT 4210764 STANDALONE 16 X 14 X 7MM
00613994502094IMPLANT 4210664 STANDALONE 16 X 14 X 6MM
00613994502087IMPLANT 4210564 STANDALONE 16 X 14 X 5MM

Trademark Results [PEEK PREVAIL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEEK PREVAIL
PEEK PREVAIL
77243971 3616753 Dead/Cancelled
Warsaw Orthopedic, Inc.
2007-08-01

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