GMK Sphere Total Knee System

GUDID 07630030827013

Tibial Insert Fixed SPHERE Flex #6/14 mm L

Medacta International SA

Tibial insert
Primary Device ID07630030827013
NIH Device Record Key35f80150-a6ba-4334-b420-5453ce16d56f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK Sphere Total Knee System
Version Model Number02.12.0614FL
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
GS107630030827013 [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 Date2014-11-18

On-Brand Devices [GMK Sphere Total Knee System]

07630040707848GMK Sphere CR Tibial Insert #6R 14mm
07630040707831GMK Sphere CR Tibial Insert #6L 14mm
07630040707824GMK Sphere CR Tibial Insert #6R 13mm
07630040707817GMK Sphere CR Tibial Insert #6L 13mm
07630040707800GMK Sphere CR Tibial Insert #6R 12mm
07630040707794GMK Sphere CR Tibial Insert #6L 12mm
07630040707787GMK Sphere CR Tibial Insert #6R 11mm
07630040707770GMK Sphere CR Tibial Insert #6L 11mm
07630040707763GMK Sphere CR Tibial Insert #6R 10mm
07630040707756GMK Sphere CR Tibial Insert #6L 10mm
07630040707701GMK Sphere CR Tibial Insert #5R 14mm
07630040707695GMK Sphere CR Tibial Insert #5L 14mm
07630040707688GMK Sphere CR Tibial Insert #5R 13mm
07630040707671GMK Sphere CR Tibial Insert #5L 13mm
07630040707664GMK Sphere CR Tibial Insert #5R 12mm
07630040707657GMK Sphere CR Tibial Insert #5L 12mm
07630040707640GMK Sphere CR Tibial Insert #5R 11mm
07630040707633GMK Sphere CR Tibial Insert #5L 11mm
07630040707626GMK Sphere CR Tibial Insert #5R 10mm
07630040707619GMK Sphere CR Tibial Insert #5L 10mm
07630040707565GMK Sphere CR Tibial Insert #4R 14mm
07630040707558GMK Sphere CR Tibial Insert #4L 14mm
07630040707541GMK Sphere CR Tibial Insert #4R 13mm
07630040707534GMK Sphere CR Tibial Insert #4L 13mm
07630040707527GMK Sphere CR Tibial Insert #4R 12mm
07630040707510GMK Sphere CR Tibial Insert #4L 12mm
07630040707503GMK Sphere CR Tibial Insert #4R 11mm
07630040707497GMK Sphere CR Tibial Insert #4L 11mm
07630040707480GMK Sphere CR Tibial Insert #4R 10mm
07630040707473GMK Sphere CR Tibial Insert #4L 10mm
07630040707428GMK Sphere CR Tibial Insert #3R 14mm
07630040707411GMK Sphere CR Tibial Insert #3L 14mm
07630040707404GMK Sphere CR Tibial Insert #3R 13mm
07630040707398GMK Sphere CR Tibial Insert #3L 13mm
07630040707381GMK Sphere CR Tibial Insert #3R 12mm
07630040707374GMK Sphere CR Tibial Insert #3L 12mm
07630040707367GMK Sphere CR Tibial Insert #3R 11mm
07630040707350GMK Sphere CR Tibial Insert #3L 11mm
07630040707343GMK Sphere CR Tibial Insert #3R 10mm
07630040707336GMK Sphere CR Tibial Insert #3L 10mm
07630040707282GMK Sphere CR Tibial Insert #2R 14mm
07630040707275GMK Sphere CR Tibial Insert #2L 14mm
07630040707268GMK Sphere CR Tibial Insert #2R 13mm
07630040707251GMK Sphere CR Tibial Insert #2L 13mm
07630040707244GMK Sphere CR Tibial Insert #2R 12mm
07630040707237GMK Sphere CR Tibial Insert #2L 12mm
07630040707220GMK Sphere CR Tibial Insert #2R 11mm
07630040707213GMK Sphere CR Tibial Insert #2L 11mm
07630040707206GMK Sphere CR Tibial Insert #2R 10mm
07630040707190GMK Sphere CR Tibial Insert #2L 10mm

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