FDA.reportPublic FDA data

Mirror™

Primary DI
M543100325
Brand
Mirror™
Company
CAYENNE MEDICAL, INC.
Model
100325
Device description
Tibial insert, flat (RM/LL-48x9mm)
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
M543100325PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

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