| Primary Device ID | 07630345732057 |
| NIH Device Record Key | c2f49c81-70f1-4805-a5a4-f1e5d60407c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NextAR TKA Platform |
| Version Model Number | 02.23.10.0031 |
| 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 | 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 | 07630345732057 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2021-07-14 |
| 07630971281370 | NextAR micrometric cutting guide cut slot |
| 07630971281363 | NextAR micrometric cutting guide connection plate |
| 07630971281356 | NextAR micrometric cutting guide |
| 07630971281349 | NextAR cut checker femur-tibia |
| 07630971281332 | NextAR 4in1 holder for GMK Efficiency |
| 07630971281325 | NextAR trial tibial baseplate holder for GMK Efficiency |
| 07630971281318 | NextAR curved stylus |
| 07630971281301 | NextAR straight stylus |
| 07630971281295 | NextAR modular tracker holder |
| 07630971281288 | NextAR tracker holder right |
| 07630971281271 | NextAR tracker holder left |
| 07630971267565 | NextAR active infrared tracker small (18) |
| 07630971267558 | NextAR infrared camera |
| 07630345732170 | Screwdriver Torx T15 |
| 07630345732163 | NextAR drilling guide for sensor holders |
| 07630345732156 | NextAR sleeve for micrometric cutting guide |
| 07630345732149 | NextAR Cut checker conical connection |
| 07630345732132 | NextAR Slot checker conical connection |
| 07630345732125 | NextAR GMK Eff trial baseplate holder conical conn |
| 07630345732118 | NextAR GMK Eff 4in1 holder conical conn |
| 07630345732101 | NextAR large handle conical connection right |
| 07630345732095 | NextAR large handle conical connection left |
| 07630345732088 | NextAR small handle conical connection right |
| 07630345732071 | NextAR small handle conical connection left |
| 07630345732064 | NextAR curved stylus conical connection |
| 07630345732057 | NextAR Straight stylus conical connection |
| 07630345732040 | NextAR small target holder left |
| 07630345732033 | NextAR small camera holder left |
| 07630345732026 | NextAR small target holder right |
| 07630345732019 | NextAR small camera holder right |
| 07630345732002 | NextAR Micrometric guide small |
| 07630345717962 | NextAR 2.0 instruments tray |
| 07630345749949 | NextAR GMK Metal trial basepl holder conical conn |
| 07630345749932 | NextAR GMK 4in1 slot holder conical conn |
| 07630345775702 | NextAR Micrometric Guide Shim +4mm |
| 07630345775696 | NextAR Micrometric Guide Shim +3mm |
| 07630345775689 | NextAR Micrometric Guide Shim +2mm |
| 07630345775672 | NextAR Micrometric Guide Shim +1mm |
| 07630345775665 | NextAR Micrometric Guide Shim 0mm |
| 07630345775658 | NextAR Micrometric Guide Shim -1mm |
| 07630345775641 | NextAR Micrometric Guide Shim -2mm |
| 07630345775634 | NextAR Micrometric Guide Shim -3mm |
| 07630345775627 | NextAR Micrometric Guide Shim -4mm |
| 07630345775610 | NextAR Micrometric Guide – Height Adjustment |
| 07630971289215 | NextAR micrometric cutting guide connection fork |
| 07630971289208 | NextAR cutting guide GMK efficiency |
| 07630971289192 | NextAR cut verifier |
| 07630971288829 | NextAR PSI-free drilling guide tibia |
| 07630971288812 | NextAR PSI-free drilling guide femur |
| 07630971288805 | NextAR PSI-free tracker holder right |