Knee Instruments

GUDID 07630030878220

Tibial FIXED STD-PS S6 Instrument Set

Medacta International SA

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID07630030878220
NIH Device Record Keyd0228726-a97a-4ecb-9d09-c8a64361ad2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnee Instruments
Version Model Number11.00026
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030878220 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [Knee Instruments]

07630971234840Large tibial base plate impactor
07630971230668Global Instrument Tibial palpator 8 mm MIS
07630971230651Global Instrument Tibial Palpator 2mm MIS
07630971230620Cutting sizer
07630971216143Reamer 28
07630971216136Reamer 24
07630971216129Reamer 20
07630971216112Reamer guide 28 Evolis
07630971216105Reamer guide 24
07630971216099Reamer guide 20
07630971216037Drilling guide
07630971216020Superior insert for impaction
07630971216013Inferior insert for patella clamp
07630971216006Patella cutting guide Right
07630971215993Patella cutting guide Left
07630971215979chisel
07630971215948Drill bit guide Ø10 mm
07630971215931Puncher #5/6
07630971215924Puncher #3/4
07630971215917Puncher #1/2
07630971215894Sliding handle
07630971215863Femoral extractor
07630971215849Impaction/extraction punch handle
07630971215214Drill bit AO connection 10 mm
07630971215191Drill bit AO connection 5 mm
07630971215177Screwdriver 3.5 mm
07630971215160Assembly posterior stabilized cam insert
07630971215153Cam for postero stabilized trial femur
07630971215146Trial base plate handle
07630971215115Pin 3.2 L 55 mm
07630971215108Pin 2.7 L 30 mm
07630971215054Drill bit 2.7 mm
07630971215047Femoral Intramedullary rod 8 mm
07630971215030Trial inset patella 28
07630971215023Trial inset patella 24
07630971215016Trial inset patella 20
07630971215009Trial resurfacing patella 39
07630971214996Trial resurfacing patella 36
07630971214989Trial resurfacing patella 33
07630971214972Trial resurfacing patella 30
07630971214965Trial insert # 6/19 mm
07630971214958Trial insert # 6/16 mm
07630971214941Trial insert # 6/13 mm
07630971214934Trial insert # 6/11 mm
07630971214118Correc.Distal MIS Cutting Guide +2°Var/Valg Unslot
07630971214071MIS - Femoral Cutting Guide 4/1 - #6
07630971214064MIS - Femoral Cutting Guide 4/1 - #5
07630971214057MIS - Femoral Cutting Guide 4/1 - #4
07630971214040MIS - Femoral Cutting Guide 4/1 - #3
07630971214033MIS - Femoral Cutting Guide 4/1 - #2

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