FDA.reportPublic FDA data

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis

Primary DI
05055196901179
Brand
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
Company
CORIN LTD
Model
379.127
Catalog number
379.127
Device description
INTRODUCER ALIGNMENT GUIDE ROD
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXAProsthesis, hip, femoral, resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXAProsthesis, Hip, Femoral, ResurfacingOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994153000CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESISCorin USA2000-02-25KXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196901179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196901179050551969011795055196901179

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866rachel.king@coringroup.com
+441285659866lucinda.gerber@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139244933Apollo KneeTKR.BB.14022025-04-07
05056139244940Apollo KneeTKR.BB.14032025-04-07
05056139244971Apollo KneeTKR.IN.16002025-04-07
05056139244988Apollo KneeTKR.IN.17002025-04-07
05056139244995Apollo KneeTKR.BB.17002025-04-07
05056139245008Apollo KneeTKR.BB.17012025-04-07
05056139245015Apollo KneeTKR.BB.17022025-04-07
05056139245022Apollo KneeTKR.BB.17032025-04-07
05056139245039Apollo KneeTKR.BB.17042025-04-07
05056139245053Apollo KneeTKR.BB.17052025-04-07
05056139245060Apollo KneeTKR.BB.17062025-04-07
05056139245077Apollo KneeTKR.BB.17072025-04-07
05056139245145Apollo KneeTKR.IN.18002025-04-07
05056139245176Apollo KneeTKR.BB.15002025-04-07
05056139245718Apollo KneeTKR.IN.14002025-04-07
05056139245770Apollo KneeTKR.BB.11002025-04-07
05056139245787Apollo KneeTKR.BB.11012025-04-07
05056139245794Apollo KneeTKR.BB.11022025-04-07
05056139245800Apollo KneeTKR.BB.11032025-04-07
05056139245817Apollo KneeTKR.BB.12002025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814193025654SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025661SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025678SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025685SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025692SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025708SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025715SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025722SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025753SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025739SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00814193025746SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00810068850383Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850444Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850451Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850468Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
05055196901087Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901094Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901100Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901117Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901124Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901162Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901186Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901193Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901209Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901216Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17