MyKnee
GUDID 07630040714556
MyKnee STD TibPinPosit-MRI-GMK-LM-#5
Medacta International SA
Orthopaedic prosthesis implantation instrument, single-use| Primary Device ID | 07630040714556 |
| NIH Device Record Key | b0d7ecf6-dfb9-44c7-a62e-cf1015d20504 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyKnee |
| Version Model Number | 8.2035 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630040714556 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170106
FDA Product Code
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
[07630040714556]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2021-01-20 |
On-Brand Devices [MyKnee]
| 07630030875267 | MyKnee Crossover Tibia Cut Adapter MIS Left |
| 07630030875243 | MyKnee Crossover Tibia Cut Adapter MIS Right |
| 07630030875229 | MyKnee Crossover Tibia Cut Adapter STD |
| 07630030875205 | MyKnee Crossover Femur Adapter Even 4in1s |
| 07630030875182 | MyKnee Crossover Femur Adapter Odd 4in1s |
| 07630030875168 | MyKnee Crossover Femur Distal Adapter MIS |
| 07630030875144 | MyKnee Crossover Femur Distal Adapter STD |
| 07630040733427 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#7 |
| 07630040733380 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#6 |
| 07630040733342 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#5 |
| 07630040733304 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#4 |
| 07630040733267 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#3 |
| 07630040733229 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#2 |
| 07630040733182 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#1 |
| 07630040733168 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#7 |
| 07630040733120 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#6 |
| 07630040733083 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#5 |
| 07630040733045 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#4 |
| 07630040733007 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#3 |
| 07630040732963 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#2 |
| 07630040732925 | MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#1 |
| 07630040715454 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#7 |
| 07630040715416 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#6 |
| 07630040715379 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#5 |
| 07630040715331 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#4 |
| 07630040715294 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#3 |
| 07630040715256 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#2 |
| 07630040715218 | MyKnee Effic STD FemPinPosit-MRI-GMK-R-#1 |
| 07630040715195 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#7 |
| 07630040715157 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#6 |
| 07630040715119 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#5 |
| 07630040715072 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#4 |
| 07630040715034 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#3 |
| 07630040714990 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#2 |
| 07630040714952 | MyKnee Effic STD FemPinPosit-MRI-GMK-L-#1 |
| 07630040714938 | MyKnee STD TibPinPosit-MRI-GMK-RL-#6 |
| 07630040714914 | MyKnee STD TibPinPosit-MRI-GMK-RL-#5 |
| 07630040714891 | MyKnee STD TibPinPosit-MRI-GMK-RL-#4 |
| 07630040714877 | MyKnee STD TibPinPosit-MRI-GMK-RL-#3 |
| 07630040714853 | MyKnee STD TibPinPosit-MRI-GMK-RL-#2 |
| 07630040714839 | MyKnee STD TibPinPosit-MRI-GMK-RL-#1 |
| 07630040714815 | MyKnee STD TibPinPosit-MRI-GMK-LL-#6 |
| 07630040714792 | MyKnee STD TibPinPosit-MRI-GMK-LL-#5 |
| 07630040714778 | MyKnee STD TibPinPosit-MRI-GMK-LL-#4 |
| 07630040714754 | MyKnee STD TibPinPosit-MRI-GMK-LL-#3 |
| 07630040714730 | MyKnee STD TibPinPosit-MRI-GMK-LL-#2 |
| 07630040714716 | MyKnee STD TibPinPosit-MRI-GMK-LL-#1 |
| 07630040714693 | MyKnee STD TibPinPosit-MRI-GMK-RM-#6 |
| 07630040714679 | MyKnee STD TibPinPosit-MRI-GMK-RM-#5 |
| 07630040714655 | MyKnee STD TibPinPosit-MRI-GMK-RM-#4 |
Trademark Results [MyKnee]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYKNEE 79072324 3828496 Live/Registered |
Medacta International SA 2009-07-13 |
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