CAPSTONE CONTROL™ Spinal System

GUDID 00643169316447

TRIAL X1012418 0DEG 22MM x 16MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage
Primary Device ID00643169316447
NIH Device Record Keyb4c0223f-df60-4eba-8ed2-7f26ef29be41
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPSTONE CONTROL™ Spinal System
Version Model NumberX1012418
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 Usefalse
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

Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169316447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169316447]

Moist Heat or Steam Sterilization


[00643169316447]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-06-30

On-Brand Devices [CAPSTONE CONTROL™ Spinal System]

00643169109827SPACER 4001427 6 DEG 14X27
00643169109810SPACER 4001422 6 DEG 14X22
00643169109803SPACER 4001332 6 DEG 13X32
00643169109797SPACER 4001327 6 DEG 13X27
00643169109780SPACER 4001322 6 DEG 13X22
00643169109773SPACER 4001232 6 DEG 12X32
00643169109766SPACER 4001227 6 DEG 12X27
00643169109759SPACER 4001222 6 DEG 12X22
00643169109742SPACER 4001132 6 DEG 11X32
00643169109735SPACER 4001127 6 DEG 11X27
00643169109728SPACER 4001122 6 DEG 11X22
00643169109711SPACER 4001027 6 DEG 10X27
00643169109704SPACER 4001022 6 DEG 10X22
00643169109667SPACER 4001732 6 DEG 17X32
00643169109650SPACER 4001727 6 DEG 17X27
00643169109643SPACER 4001722 6 DEG 17X22
00643169109636SPACER 4001632 6 DEG 16X32
00643169109629SPACER 4001627 6 DEG 16X27
00643169109612SPACER 4001622 6 DEG 16X22
00643169109605SPACER 4001532 6 DEG 15X32
00643169109599SPACER 4001527 6 DEG 15X27
00643169109582SPACER 4001522 6 DEG 15X22
00643169109575SPACER 4001432 6 DEG 14X32
00643169109094SPACER 4021622 18 DEG 16X22
00643169109087SPACER 4021522 18 DEG 15X22
00643169109070SPACER 4011222 12 DEG 12X22
00643169109063SPACER 4011122 12 DEG 11X22
00643169109056SPACER 4011022 12 DEG 10X22
00643169109049SPACER 4021422 18 DEG 14X22
00643169109032SPACER 4021322 18 DEG 13X22
00643169109018SPACER 4011722 12 DEG 17X22
00643169109001SPACER 4011622 12 DEG 16X22
00643169108998SPACER 4011522 12 DEG 15X22
00643169108981SPACER 4011422 12 DEG 14X22
00643169108974SPACER 4011322 12 DEG 13X22
00643169108967SPACER 4021722 18 DEG 17X22
00643169108943SPACER 4021727 18 DEG 17X27
00643169108936SPACER 4021627 18 DEG 16X27
00643169108929SPACER 4021527 18 DEG 15X27
00643169108912SPACER 4021427 18 DEG 14X27
00643169108899SPACER 4011727 12 DEG 17X27
00643169108882SPACER 4011627 12 DEG 16X27
00643169108875SPACER 4011527 12 DEG 15X27
00643169108868SPACER 4011427 12 DEG 14X27
00643169108851SPACER 4011327 12 DEG 13X27
00643169108844SPACER 4011227 12 DEG 12X27
00643169092129TRAY 3990052 SPREADER TRIALS- 2
00643169092112TRAY 3990051 SPREADER TRIALS- 1
00643169092105TRAY 3990050 GENERAL INSTRUMENTS
00643169055759SPACER 3991327 CAPSTONE IR 0 DEG 13X27

Trademark Results [CAPSTONE CONTROL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSTONE CONTROL
CAPSTONE CONTROL
85253149 4324898 Live/Registered
Medtronic, Inc.
2011-02-28

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