| Primary Device ID | 07630971275003 |
| NIH Device Record Key | b6617cce-6b72-4268-a6cc-1fa4d8175ef0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyKnee NextAR Femur Distal Cutting Block Efficiency |
| Version Model Number | 16.1014M |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07630971275003 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
[07630971275003]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-01 |
| Device Publish Date | 2020-08-24 |
| 07630971276925 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #7 |
| 07630971276888 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #6 |
| 07630971276840 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #5 |
| 07630971276802 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #4 |
| 07630971276765 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #3 |
| 07630971276727 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #2 |
| 07630971276680 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #1 |
| 07630971276666 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #7 |
| 07630971276628 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #6 |
| 07630971276581 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #5 |
| 07630971276543 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #4 |
| 07630971276505 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #3 |
| 07630971276468 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #2 |
| 07630971276437 | MyKnee NextAR Femur Distal Cutting Block Efficiency - MRI - GMK - Left Medial - #1+ |
| 07630971276420 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #1 |
| 07630971275379 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #7 |
| 07630971275348 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #6+ |
| 07630971275331 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #6 |
| 07630971275300 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #5+ |
| 07630971275294 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #5 |
| 07630971275263 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #4+ |
| 07630971275256 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #4 |
| 07630971275225 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #3+ |
| 07630971275218 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #3 |
| 07630971275188 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #2+ |
| 07630971275171 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #2 |
| 07630971275140 | MyKnee NextAR Femur Distal Cutting Block Efficiency - CT - GMK - Right Medial - #1+ |
| 07630971275133 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Right Medial - #1 |
| 07630971275119 | MyKnee NextAR Femur Distal Cutting Block Efficiency - CT - GMK - Left Medial - #7 |
| 07630971275089 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #6+ |
| 07630971275072 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #6 |
| 07630971275041 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #5+ |
| 07630971275034 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #5 |
| 07630971275003 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #4+ |
| 07630971274990 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #4 |
| 07630971274969 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #3+ |
| 07630971274952 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #3 |
| 07630971274921 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #2+ |
| 07630971274914 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #2 |
| 07630971274884 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #1+ |
| 07630971274877 | MyKnee NextAR Femur Distal Cutting Block Efficiency – CT - GMK - Left Medial - #1 |
| 07630971276932 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #7 - STERILE |
| 07630971276918 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #6+ - STERILE |
| 07630971276901 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #6 - STERILE |
| 07630971276895 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #6+ |
| 07630971276871 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #5+ - STERILE |
| 07630971276864 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #5 - STERILE |
| 07630971276857 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #5+ |
| 07630971276833 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #4+ - STERILE |
| 07630971276826 | MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Right Medial - #4 - STERILE |