FDA.reportPublic FDA data

KneeTec PFJ

Primary DI
05056139221279
Brand
KneeTec PFJ
Company
CORIN LTD
Model
MDI422
Catalog number
MDI422
Device description
Drill Bit for Pegs
Published
2018-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056139221279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056139221279050561392212795056139221279

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
+330456608978severine.siracusa@coringroup.c
+330456608978severine.siracusa@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055343887592Cenator Total Hip System299.01100000000002299.011000000000022022-12-08
05056139213335MobiliT CupMCT706MCT7062022-12-08
05056139223075MobiliT CupMDM001MDM0012022-12-08
05056139223082MobiliT CupMDM002MDM0022022-12-08
05056139223280MobiliT CupMDM042MDM0432022-12-08
05056139223297MobiliT CupMDM044MDM0452022-12-08
05056139223303MobiliT CupMDM046MDM0472022-12-08
05056139223310MobiliT CupMDM048MDM0492022-12-08
05056139223327MobiliT CupMDM050MDM0512022-12-08
05056139223334MobiliT CupMDM052MDM0532022-12-08
05056139223341MobiliT CupMDM054MDM0552022-12-08
05056139223358MobiliT CupMDM056MDM0572022-12-08
05056139223365MobiliT CupMDM058MDM0592022-12-08
05056139223372MobiliT CupMDM060MDM0612022-12-08
05056139223389MobiliT CupMDM062MDM0632022-12-08
05056139223396MobiliT CupMDM064MDM0642022-12-08
05056139223402MobiliT CupMDM066MDM0672022-12-08
05056139223419MobiliT CupMDM068MDM0692022-12-08
05056139240881MobiliT CupMDM042AMDM042A2022-12-08
05056139240898MobiliT CupMDM044AMDM044A2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPIS18100PF0Episealer Knee Revision GuideEpisurf Operations ABKRR2023-07-24
EPIS31120PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS31125PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS31129PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS32120PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS32125PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS32129PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS33120PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33125PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33129PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33420PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33425PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33429PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33720PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS33725PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS33729PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS34120PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS34125PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS34129PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS37320PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS37325PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS37329PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS51117PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS51120PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS51125PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS52117PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS52120PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS52125PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS53117PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS53120PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24