ANATOMIC PEEK PTC Cervical Fusion System

GUDID 00643169411951

ANATOMIC PEEK PTC X1013044 9X18X16

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile
Primary Device ID00643169411951
NIH Device Record Key98da962b-bf53-4190-b1d2-f65767c3d0f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameANATOMIC PEEK PTC Cervical Fusion System
Version Model NumberX1013044
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169411951 [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 Date2016-04-03

On-Brand Devices [ANATOMIC PEEK PTC Cervical Fusion System]

00643169412002ANATOMIC PEEK PTC X1013049 14X18X16
00643169411999ANATOMIC PEEK PTC X1013048 13X18X16
00643169411982ANATOMIC PEEK PTC X1013047 12X18X16
00643169411975ANATOMIC PEEK PTC X1013046 11X18X16
00643169411968ANATOMIC PEEK PTC X1013045 10X18X16
00643169411951ANATOMIC PEEK PTC X1013044 9X18X16
00643169411944ANATOMIC PEEK PTC X1013043 8X18X16
00643169411937ANATOMIC PEEK PTC X1013042 7X18X16
00643169411920ANATOMIC PEEK PTC X1013041 6X18X16
00643169411913ANATOMIC PEEK PTC X1013040 5X18X16
00643169411906ANATOMIC PEEK PTC X1013039 14X16X14
00643169411890ANATOMIC PEEK PTC X1013038 13X16X14
00643169411883ANATOMIC PEEK PTC X1013037 12X16X14
00643169411876ANATOMIC PEEK PTC X1013036 11X16X14
00643169411869ANATOMIC PEEK PTC X1013035 10X16X14
00643169408036CAGE 5030386 ANATOMIC PTC 18X16X13MM
00643169357709CAGE 5030441 ANATOMIC PTC 14X11X14MM
00643169357686CAGE 5030341 ANATOMIC PTC 14X11X13MM
00643169357655CAGE 5030241 ANATOMIC PTC 14X11X12MM
00643169357624CAGE 5030141 ANATOMIC PTC 14X11X11MM
00643169357600CAGE 5030064 ANATOMIC PTC 16X14X10MM
00643169357594CAGE 5030041 ANATOMIC PTC 14X11X10MM
00643169357587CAGE 5030541 ANATOMIC PTC 14X11X5MM
00643169357570CAGE 5030564 ANATOMIC PTC 16X14X5MM
00643169357556CAGE 5030641 ANATOMIC PTC 14X11X6MM
00643169357549CAGE 5030664 ANATOMIC PTC 16X14X6MM
00643169357525CAGE 5030741 ANATOMIC PTC 14X11X7MM
00643169357518CAGE 5030764 ANATOMIC PTC 16X14X7MM
00643169357495CAGE 5030841 ANATOMIC PTC 14X11X8MM
00643169357488CAGE 5030864 ANATOMIC PTC 16X14X8MM
00643169357464CAGE 5030941 ANATOMIC PTC 14X11X9MM
00643169357457CAGE 5030964 ANATOMIC PTC 16X14X9MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.