MyKnee STD

GUDID 07630030889325

MyKnee STD FemDisCutBl-CT-GMK-RM-#2

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

Primary Device ID	07630030889325
NIH Device Record Key	c3600b5f-3141-429d-8fec-30e9331a83e9
Commercial Distribution Status	In Commercial Distribution
Brand Name	MyKnee STD
Version Model Number	6.1022
Company DUNS	488227125
Company Name	Medacta International SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030889325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093806

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer