FairFix Adjustable Button System

GUDID 07630345778703

FairFix PSP Adjustable Button

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID07630345778703
NIH Device Record Keyd79df3bd-ff1e-4ae8-8ba6-5ba2aae34f1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFairFix Adjustable Button System
Version Model Number05.05.0122
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
GS107630345778703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-13

On-Brand Devices [FairFix Adjustable Button System]

07630345703934FairFix Adjustable Button Extender
07630345703927FairFix Adjustable Button
07630345778703FairFix PSP Adjustable Button
07630345778697FairFix AM Adjustable Button
07630345797032FairFix Round Extender - Large
07630345797025FairFix Round Extender - Medium
07630345797018FairFix Round Extender - Small

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