CoCr Femoral Ball Head

GUDID 07630030805141

Femoral Head Ø 28 size XXL

Medacta International SA

Metallic femoral head prosthesis
Primary Device ID07630030805141
NIH Device Record Keyd7ba5629-9092-4a0e-b128-046bd87ac5a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoCr Femoral Ball Head
Version Model Number01.25.015
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
GS107630030805141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2014-11-18

On-Brand Devices [CoCr Femoral Ball Head]

07630030805486Femoral Head Ø 22 size S
07630030805479Femoral Head Ø 22 size M
07630030805370Femoral Head Ø 40 Size XXL
07630030805363Femoral Head Ø 40 Size XL
07630030805356Femoral Head Ø 40 Size L
07630030805349Femoral Head Ø 40 Size M
07630030805332Femoral Head Ø 40 Size S
07630030805240Femoral Head Ø 36 size XXL
07630030805233Femoral Head Ø 36 size XL
07630030805226Femoral Head Ø 36 size L
07630030805219Femoral Head Ø 36 size M
07630030805202Femoral Head Ø 36 size S
07630030805196Femoral Head Ø 32 size XXL
07630030805189Femoral Head Ø 32 size XL
07630030805172Femoral Head Ø 32 size L
07630030805165Femoral Head Ø 32 size M
07630030805158Femoral Head Ø 32 size S
07630030805141Femoral Head Ø 28 size XXL
07630030805134Femoral Head Ø 28 size XL
07630030805127Femoral Head Ø 28 size L
07630030805110Femoral Head Ø 28 size M
07630030805103Femoral Head Ø 28 size S

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