Primary Device ID | 07630971216136 |
NIH Device Record Key | d0418514-37ba-49ba-ae63-c0f8067c5750 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Knee Instruments |
Version Model Number | 2.224 |
Company DUNS | 488227125 |
Company Name | Medacta International SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630971216136 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
[07630971216136]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-03 |
Device Publish Date | 2020-06-25 |
07630971234840 | Large tibial base plate impactor |
07630971230668 | Global Instrument Tibial palpator 8 mm MIS |
07630971230651 | Global Instrument Tibial Palpator 2mm MIS |
07630971230620 | Cutting sizer |
07630971216143 | Reamer 28 |
07630971216136 | Reamer 24 |
07630971216129 | Reamer 20 |
07630971216112 | Reamer guide 28 Evolis |
07630971216105 | Reamer guide 24 |
07630971216099 | Reamer guide 20 |
07630971216037 | Drilling guide |
07630971216020 | Superior insert for impaction |
07630971216013 | Inferior insert for patella clamp |
07630971216006 | Patella cutting guide Right |
07630971215993 | Patella cutting guide Left |
07630971215979 | chisel |
07630971215948 | Drill bit guide Ø10 mm |
07630971215931 | Puncher #5/6 |
07630971215924 | Puncher #3/4 |
07630971215917 | Puncher #1/2 |
07630971215894 | Sliding handle |
07630971215863 | Femoral extractor |
07630971215849 | Impaction/extraction punch handle |
07630971215214 | Drill bit AO connection 10 mm |
07630971215191 | Drill bit AO connection 5 mm |
07630971215177 | Screwdriver 3.5 mm |
07630971215160 | Assembly posterior stabilized cam insert |
07630971215153 | Cam for postero stabilized trial femur |
07630971215146 | Trial base plate handle |
07630971215115 | Pin 3.2 L 55 mm |
07630971215108 | Pin 2.7 L 30 mm |
07630971215054 | Drill bit 2.7 mm |
07630971215047 | Femoral Intramedullary rod 8 mm |
07630971215030 | Trial inset patella 28 |
07630971215023 | Trial inset patella 24 |
07630971215016 | Trial inset patella 20 |
07630971215009 | Trial resurfacing patella 39 |
07630971214996 | Trial resurfacing patella 36 |
07630971214989 | Trial resurfacing patella 33 |
07630971214972 | Trial resurfacing patella 30 |
07630971214965 | Trial insert # 6/19 mm |
07630971214958 | Trial insert # 6/16 mm |
07630971214941 | Trial insert # 6/13 mm |
07630971214934 | Trial insert # 6/11 mm |
07630971214118 | Correc.Distal MIS Cutting Guide +2°Var/Valg Unslot |
07630971214071 | MIS - Femoral Cutting Guide 4/1 - #6 |
07630971214064 | MIS - Femoral Cutting Guide 4/1 - #5 |
07630971214057 | MIS - Femoral Cutting Guide 4/1 - #4 |
07630971214040 | MIS - Femoral Cutting Guide 4/1 - #3 |
07630971214033 | MIS - Femoral Cutting Guide 4/1 - #2 |