My Spine Placement Guides

GUDID 07630971262744

MySpine vertebra T13

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630971262744
NIH Device Record Keyc214179a-1987-4d45-9632-e6b56124828a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Spine Placement Guides
Version Model Number7.0013
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
GS107630971262744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


[07630971262744]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-18
Device Publish Date2022-02-10

On-Brand Devices [My Spine Placement Guides]

07630971262744MySpine vertebra T13
07630971262676MySpine drill guide T13 STERILE
07630971262669MySpine drill guide T13
07630971262577MySpine vertebra T13 STERILE
07630971257764MySpine drill guide L06 STERILE
07630971257757MySpine drill guide L06
07630971257733MySpine vertebra L06 STERILE
07630971257726MySpine vertebra L06

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