FDA.reportPublic FDA data

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis

Primary DI
05055196901162
Brand
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
Company
CORIN LTD
Model
379.126
Catalog number
379.126
Device description
LOCKING SCREW WRENCH
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
05055196901162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196901162050551969011625055196901162

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
05055196901179Cormet 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