PHYSICA Instrument Set 9065.10.062

GUDID 08033390104296

H.2mm Fem. A/P Sizer Post. Augments

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08033390104296
NIH Device Record Key840b8422-a2e6-4773-8949-10ad678f97af
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSICA Instrument Set
Version Model NumberAugments
Catalog Number9065.10.062
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
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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390104296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


[08033390104296]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-03
Device Publish Date2016-05-25

On-Brand Devices [PHYSICA Instrument Set]

08033390103572Femoral Trial/PS Box Guide Inserter/Extractor
08033390099752Femoral Peg Inserter
08033390097956Femoral Positioner Inserter/Extractor
08033390097666Tibial Positioner Inserter/Extractor
08033390110464Trial Patella D.32mm h.8.5mm
08033390110457Trial Patella D.29mm h.7mm
08033390110440Trial Patella D.26mm h.7mm
08033390093576Guide Tibial Winged Broach-#9-#10
08033390093569Guide Tibial Winged Broach-#1-#2
08033390090513Guide Tibial Winged Broach-#6-#7-#8
08033390090506Guide Tibial Winged Broach-#3-#4-#5
08033390090933Tibial Reamer
08033390107990Extension Spacer H10mm
08033390107983Trial Tibial Plate #10
08033390107976Trial Tibial Plate #9
08033390107969Trial Tibial Plate #8
08033390107952Trial Tibial Plate #7
08033390107945Trial Tibial Plate #6
08033390107938Trial Tibial Plate #5
08033390107921Trial Tibial Plate #4
08033390107914Trial Tibial Plate #3
08033390107907Trial Tibial Plate #2
08033390107891Trial Tibial Plate #1
08033390104371H16mm Extension Spacer
08033390104364H14mm Extension Spacer
08033390104357H12mm Extension Spacer
08033390104340H11mm Extension Spacer
08033390104333H10mm Extension Spacer
08033390097505PS Trial Liner #10 - H.20mm
08033390097499PS Trial Liner #9 - H.20mm
08033390097482PS Trial Liner #8 - H.20mm
08033390097475PS Trial Liner #7 - H.20mm
08033390097468PS Trial Liner #6 - H.20mm
08033390097451PS Trial Liner #5 - H.20mm
08033390097444PS Trial Liner #4 - H.20mm
08033390097437PS Trial Liner #3 - H.20mm
08033390097420PS Trial Liner #2 - H.20mm
08033390097413PS Trial Liner #1 - H.20mm
08033390097406PS Trial Liner #10 - H.16mm
08033390097390PS Trial Liner #9 - H.16mm
08033390097383PS Trial Liner #8 - H.16mm
08033390097376PS Trial Liner #7 - H.16mm
08033390097369PS Trial Liner #6 - H.16mm
08033390097352PS Trial Liner #5 - H.16mm
08033390097345PS Trial Liner #4 - H.16mm
08033390097338PS Trial Liner #3 - H.16mm
08033390097321PS Trial Liner #2 - H.16mm
08033390097314PS Trial Liner #1 - H.16mm
08033390097307PS Trial Liner #10 - H.14mm
08033390097291PS Trial Liner #9 - H.14mm

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