FDA.reportPublic FDA data

Mirror™

Primary DI
M543100297
Brand
Mirror™
Company
CAYENNE MEDICAL, INC.
Model
100297
Device description
Tibial baseplate with pegs (RM/LL-48mm)
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543100297PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee tibia prosthesis, metallicA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606719685
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M543CM8010Quattro®CM-8010CM-80102019-03-29
M543CM6127BioWick SureLockCM-61272016-01-10
M543CM6255BioWick XCM-62552018-01-31
M543CM6265BioWick XCM-62652018-01-25
00887868269769BioWick® SureLock®CM-61272020-09-21
00887868269790BioWick® XCM-62552020-09-21
00887868269813BioWick® XCM-62652020-09-21
M5431100259901Ventix™1100259901100259902018-12-04
M5431100259921Ventix™1100259921100259922018-12-04
M543CM1025iFix®CM-10252015-10-09
M543CM1030iFix®CM-10302015-10-09
M543CM1130iFix®CM-11302015-10-09
M543CM1230iFix®CM-12302015-10-09
M543CM1720iFix®CM-17202015-10-09
M543CM1725iFix®CM-17252015-10-09
M543CM1820iFix®CM-18202015-10-09
M543CM1825iFix®CM-18252015-10-09
M543CM1830iFix®CM-18302015-10-09
M543CM1920iFix®CM-19202015-10-09
M543CM1925iFix®CM-19252015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
00888867106697Arthrex®ARTHREX, INC.HSX2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016401MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016418MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016432MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016449MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016456MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016463MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016487MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016494MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016494MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016500MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016500MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016517MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016517MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016531MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016531MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016548MakoMAKO SURGICAL CORP.HRY2015-11-04
00848486016548MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016555MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016555MakoMAKO SURGICAL CORP.HRY2015-11-04