Mectacer Biolox Delta Femoral Ball Head

GUDID 07630030809255

Femoral Head Ø 40 Size L

Medacta International SA

Ceramic femoral head prosthesis
Primary Device ID07630030809255
NIH Device Record Key110c9185-18ce-4b4a-a165-90540a54e6d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMectacer Biolox Delta Femoral Ball Head
Version Model Number01.29.214
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
GS107630030809255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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 [Mectacer Biolox Delta Femoral Ball Head]

07630030809309Femoral Head Ø 44 Size XL
07630030809293Femoral Head Ø 44 Size L
07630030809286Femoral Head Ø 44 Size M
07630030809279Femoral Head Ø 44 Size S
07630030809262Femoral Head Ø 40 Size XL
07630030809255Femoral Head Ø 40 Size L
07630030809248Femoral Head Ø 40 Size M
07630030809231Femoral Head Ø 40 Size S
07630030809224Femoral Head Ø 36 Size XL
07630030809217Femoral Head Ø 36 Size L
07630030809200Femoral Head Ø 36 Size M
07630030809194Femoral Head Ø 36 Size S
07630030809187Femoral Head Ø 32 Size XL
07630030809170Femoral Head Ø 32 Size L
07630030809163Femoral Head Ø 32 Size M
07630030809156Femoral Head Ø 32 Size S
07630030809149Femoral Head Ø 28 Size L
07630030809132Femoral Head Ø 28 Size M
07630030809125Femoral Head Ø 28 Size S

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