PHYSICA KR 9065.11.560

GUDID 08033390088107

#6-Left-Trial Femoral Component

LIMACORPORATE SPA

Knee femur prosthesis trial, reusable
Primary Device ID08033390088107
NIH Device Record Key1f34e036-86b6-48e2-83d7-df0f4613b6bd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSICA KR
Version Model NumberTrial Femoral Component
Catalog Number9065.11.560
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390088107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

[08033390088107]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2022-03-22
Device Publish Date2016-05-14

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.