CAPSTONE PTC™ Spinal System

GUDID 00643169187467

SPACER 3992606 26MM X 6MM

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile
Primary Device ID00643169187467
NIH Device Record Keyc1f72790-7ce9-48ff-a7d6-7868f050c0f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPSTONE PTC™ Spinal System
Version Model Number3992606
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 Perscriptionfalse
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100643169187467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

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 Date2016-04-17

On-Brand Devices [CAPSTONE PTC™ Spinal System]

00643169187573SPACER 3992206 22MM X 6MM
00643169187566SPACER 3992207 22MM X 7MM
00643169187559SPACER 3992208 22MM X 8MM
00643169187542SPACER 3992209 22MM X 9MM
00643169187535SPACER 3992210 22MM X 10MM
00643169187528SPACER 3992211 22MM X 11MM
00643169187511SPACER 3992212 22MM X 12MM
00643169187504SPACER 3992213 22MM X 13MM
00643169187498SPACER 3992214 22MM X 14MM
00643169187481SPACER 3992215 22MM X 15MM
00643169187474SPACER 3992216 22MM X 16MM
00643169187467SPACER 3992606 26MM X 6MM
00643169187450SPACER 3992607 26MM X 7MM
00643169187443SPACER 3992608 26MM X 8MM
00643169187436SPACER 3992609 26MM X 9MM
00643169187429SPACER 3992610 26MM X 10MM
00643169187412SPACER 3992611 26MM X 11MM
00643169187405SPACER 3992612 26MM X 12MM
00643169187399SPACER 3992613 26MM X 13MM
00643169187382SPACER 3992614 26MM X 14MM
00643169187375SPACER 3992615 26MM X 15MM
00643169187368SPACER 3992616 26MM X 16MM
00643169187351SPACER 3993207 32MM X 7MM
00643169187344SPACER 3993208 32MM X 8MM
00643169187337SPACER 3993209 32MM X 9MM
00643169187320SPACER 3993210 32MM X 10MM
00643169187313SPACER 3993211 32MM X 11MM
00643169187306SPACER 3993212 32MM X 12MM
00643169187290SPACER 3993213 32MM X 13MM
00643169187283SPACER 3993214 32MM X 14MM
00643169187276SPACER 3993215 32MM X 15MM
00643169187269SPACER 3993216 32MM X 16MM
00643169187252SPACER 3993607 36MM X 7MM
00643169187245SPACER 3993608 36MM X 8MM
00643169187238SPACER 3993609 36MM X 9MM
00643169187221SPACER 3993610 36MM X 10MM
00643169187214SPACER 3993611 36MM X 11MM
00643169187207SPACER 3993612 36MM X 12MM
00643169187191SPACER 3993613 36MM X 13MM
00643169187184SPACER 3993614 36MM X 14MM
00643169187177SPACER 3993615 36MM X 15MM
00643169187160SPACER 3993616 36MM X 16MM

Trademark Results [CAPSTONE PTC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSTONE PTC
CAPSTONE PTC
85622851 4863474 Live/Registered
Medtronic, Inc.
2012-05-11

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