ANATOMIC PEEK CERVICAL FUSION SYSTEM

GUDID 00613994360519

IMPLANT 4240886 ANATOMIC C 18X16X 8MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage
Primary Device ID00613994360519
NIH Device Record Key0e972e5b-cc03-4325-9743-e759c99bffed
Commercial Distribution StatusIn Commercial Distribution
Brand NameANATOMIC PEEK CERVICAL FUSION SYSTEM
Version Model Number4240886
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 Dimensions

Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994360519 [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 Number4
Public Version Date2020-02-24
Device Publish Date2015-07-08

On-Brand Devices [ANATOMIC PEEK CERVICAL FUSION SYSTEM]

00613994366474IMPLANT 4240564 ANATOMIC C 16X14X 5MM
00613994366467IMPLANT 4240664 ANATOMIC C 16X14X 6MM
00613994366450IMPLANT 4240764 ANATOMIC C 16X14X 7MM
00613994366443IMPLANT 4240864 ANATOMIC C 16X14X 8MM
00613994366436IMPLANT 4240964 ANATOMIC C 16X14X 9MM
00613994366429IMPLANT 4240064 ANATOMIC C 16X14X 10MM
00613994366412IMPLANT 4240164 ANATOMIC C 16X14X 11MM
00613994366405IMPLANT 4240264 ANATOMIC C 16X14X 12MM
00613994366399IMPLANT 4240364 ANATOMIC C 16X14X 13MM
00613994366382IMPLANT 4240464 ANATOMIC C 16X14X 14MM
00613994360656IMPLANT 4240541 ANATOMIC C 14X11X 5MM
00613994360649IMPLANT 4240641 ANATOMIC C 14X11X 6MM
00613994360632IMPLANT 4240741 ANATOMIC C 14X11X 7MM
00613994360625IMPLANT 4240841 ANATOMIC C 14X11X 8MM
00613994360618IMPLANT 4240941 ANATOMIC C 14X11X 9MM
00613994360601IMPLANT 4240041 ANATOMIC C 14X11X 10MM
00613994360595IMPLANT 4240141 ANATOMIC C 14X11X 11MM
00613994360588IMPLANT 4240241 ANATOMIC C 14X11X 12MM
00613994360571IMPLANT 4240341 ANATOMIC C 14X11X 13MM
00613994360564IMPLANT 4240441 ANATOMIC C 14X11X 14MM
00613994360540IMPLANT 4240586 ANATOMIC C 18X16X 5MM
00613994360533IMPLANT 4240686 ANATOMIC C 18X16X 6MM
00613994360526IMPLANT 4240786 ANATOMIC C 18X16X 7MM
00613994360519IMPLANT 4240886 ANATOMIC C 18X16X 8MM
00613994360502IMPLANT 4240986 ANATOMIC C 18X16X 9MM
00613994360496IMPLANT 4240086 ANATOMIC C 18X16X 10MM
00613994360489IMPLANT 4240186 ANATOMIC C 18X16X 11MM
00613994360472IMPLANT 4240286 ANATOMIC C 18X16X 12MM
00613994360465IMPLANT 4240386 ANATOMIC C 18X16X 13MM
00613994360458IMPLANT 4240486 ANATOMIC C 18X16X 14MM

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