FDA.report

NA

Primary DI
03596010061225
Brand
NA
Company
Smith & Nephew, Inc.
Model
120764
Catalog number
120764
Device description
TYPE II FEMORAL PATELLAR COMPONENT REG SHORT CC
Published
2015-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010061225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010061225035960100612253596010061225

GMDN Terms

TermDefinition
Patellofemoral joint prosthesisA sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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EPIS51120PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
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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