PHYSICA KR 6531.54.510

GUDID 08033390182515

PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 10 mm Right

LIMACORPORATE SPA

Tibial insert
Primary Device ID08033390182515
NIH Device Record Key1fc9f75b-d53d-4c05-879d-a1ab1c3cd1c1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSICA KR
Version Model Number6531.54.510
Catalog Number6531.54.510
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390182515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-30
Device Publish Date2020-12-22

On-Brand Devices [PHYSICA KR]

08033390087391KR Femoral Component Left #10
08033390087384KR Femoral Component Left #9
08033390087377KR Femoral Component Left #8
08033390087360KR Femoral Component Left #7
08033390087353KR Femoral Component Left #6
08033390087346KR Femoral Component Left #5
08033390087339KR Femoral Component Left #4
08033390087322KR Femoral Component Left #3
08033390087315KR Femoral Component Left #2
08033390087308KR Femoral Component Left #1
08033390087292KR Femoral Component Right #10
08033390087285KR Femoral Component Right #9
08033390087278KR Femoral Component Right #8
08033390087261KR Femoral Component Right #7
08033390087254KR Femoral Component Right #6
08033390087247KR Femoral Component Right #5
08033390087230KR Femoral Component Right #4
08033390087223KR Femoral Component Right #3
08033390087216KR Femoral Component Right #2
08033390083089KR Femoral Component Right #1
08033390182904PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 20 mm Right
08033390182898PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 16 mm Right
08033390182881PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 14 mm Right
08033390182850PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 12 mm Right
08033390182843PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 11 mm Right
08033390182836PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 10 mm Right
08033390182829PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 20 mm Right
08033390182812PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 16 mm Right
08033390182805PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 14 mm Right
08033390182713PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 12 mm Right
08033390182706PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 11 mm Right
08033390182690PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 10 mm Right
08033390182683PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 20 mm Right
08033390182614PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 16 mm Right
08033390182607PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 14 mm Right
08033390182591PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 12 mm Right
08033390182584PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 11 mm Right
08033390182577PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 10 mm Right
08033390182560PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 20 mm Right
08033390182553PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 16 mm Right
08033390182546PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 14 mm Right
08033390182539PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 12 mm Right
08033390182522PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 11 mm Right
08033390182515PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 10 mm Right
08033390182416PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 20 mm Right
08033390182379PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 16 mm Right
08033390182362PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 14 mm Right
08033390182294PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 12 mm Right
08033390182287PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 11 mm Right
08033390182270PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 10 mm Right
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