3DMetal Tibial Cones

GUDID 07630030884085

Centred S H25

Medacta International SA

Knee arthroplasty wedge
Primary Device ID07630030884085
NIH Device Record Key3a71e80d-e63a-4bd5-b3a7-c94a6f53291e
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DMetal Tibial Cones
Version Model Number02.07.CS25
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
GS107630030884085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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 Date2017-08-24

On-Brand Devices [3DMetal Tibial Cones]

07630030884146Eccentric L H25
07630030884139Eccentric M H25
07630030884122Eccentric S H25
07630030884115Eccentric S H20
07630030884108Centred L H25
07630030884092Centred M H25
07630030884085Centred S H25
07630030884078Centred S H20
07630030884061Centred XS H25
07630030884054Centred XS H20

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