MySpine

GUDID 07630040717458

MySpine-MC guide S01

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630040717458
NIH Device Record Key945a2042-1233-4836-a8bc-d358d275c22c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMySpine
Version Model Number7.0716
Company DUNS488227125
Company NameMedacta International SA
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630040717458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQCPedicle Screw Placement Guide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


[07630040717458]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-28
Device Publish Date2021-01-20

On-Brand Devices [MySpine ]

07630040716888MySpine LP drill pilot guide L05
07630040716864MySpine LP drill pilot guide L04
07630040716840MySpine LP drill pilot guide L03
07630040716826MySpine LP drill pilot guide L02
07630040716802MySpine LP drill pilot guide L01
07630040716789MySpine LP drill pilot guide T12
07630040716765MySpine LP drill pilot guide T11
07630040716741MySpine LP drill pilot guide T10
07630040716727MySpine LP drill pilot guide T09
07630040716703MySpine LP drill pilot guide T08
07630040716680MySpine LP drill pilot guide T07
07630040716666MySpine LP drill pilot guide T06
07630040716642MySpine LP drill pilot guide T05
07630040716628MySpine LP drill pilot guide T04
07630040716604MySpine LP drill pilot guide T03
07630040716581MySpine LP drill pilot guide T02
07630040716567MySpine LP drill pilot guide T01
07630971257870MySpine-MC drill guide L06
07630971257832MySpine-MC vertebra L06
07630040717571MySpine-MC drill guide S01
07630040717557MySpine-MC drill guide L05
07630040717533MySpine-MC drill guide L04
07630040717519MySpine-MC drill guide L03
07630040717496MySpine-MC drill guide L02
07630040717472MySpine-MC drill guide L01
07630040717458MySpine-MC guide S01
07630040717434MySpine-MC guide L05
07630040717410MySpine-MC guide L04
07630040717397MySpine-MC guide L03
07630040717373MySpine-MC guide L02
07630040717359MySpine-MC guide L01
07630040717335MySpine-MC vertebra S01
07630040717311MySpine-MC vertebra L05
07630040717298MySpine-MC vertebra L04
07630040717274MySpine-MC vertebra L03
07630040717250MySpine-MCvertebra L02
07630040717236MySpine-MC vertebra L01
07630971262737MySpine LP drill pilot guide T13 STERILE
07630971262720MySpine LP drill pilot guide T13
07630971257887MySpine MC drill guide L06 STERILE
07630971257863MySpine MC guide L06 STERILE
07630971257856MySpine MC guide L06
07630971257849MySpine MC vertebra L06 STERILE
07630971257825MySpine LP drill pilot guide L06 STERILE
07630971257818MySpine LP drill pilot guide L06
07630971257740Full Spine Model Short
07630345752918MySpine S2-SI right guide STE
07630345752901MySpine S2-SI right guide
07630345752895MySpine S2-SI left guide STE
07630345752888MySpine S2-SI left guide

Trademark Results [MySpine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYSPINE
MYSPINE
79072327 3828498 Live/Registered
Medacta International SA
2009-07-13

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