Mectacer Biolox Forte Femoral Ball Head

GUDID 07630030846717

Femoral Head Ø 28 Size L

Medacta International SA

Ceramic femoral head prosthesis
Primary Device ID07630030846717
NIH Device Record Key1523e6dd-fd3d-4163-b5d5-c1bfc2039ea8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMectacer Biolox Forte Femoral Ball Head
Version Model Number38.39.7175.265.00
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
GS107630030846717 [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 Forte Femoral Ball Head]

07630030846779Femoral Head Ø 36 Size L
07630030846762Femoral Head Ø 36 Size M
07630030846755Femoral Head Ø 36 Size S
07630030846748Femoral Head Ø 32 Size L
07630030846731Femoral Head Ø 32 Size M
07630030846724Femoral Head Ø 32 Size S
07630030846717Femoral Head Ø 28 Size L
07630030846700Femoral Head Ø 28 Size M
07630030846694Femoral Head Ø 28 Size S

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