| Primary Device ID | 00858704006190 |
| NIH Device Record Key | d5b2c23d-5218-415d-8be9-a04793fa632d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KneeAlign 2 |
| Version Model Number | 401578 |
| Catalog Number | 401578 |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, INC. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858704006190 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
[00858704006190]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-17 |
| Device Publish Date | 2016-09-23 |
| 00810832030393 | KneeAlign 2 Instrument Tray Base |
| 00810832030386 | KneeAlign 2 Instrument Tray Base |
| 00810832030263 | Tibial Cutting Block, Left, Rapid Traverse |
| 00810832030256 | Tibial Cutting Block, Right, Rapid Traverse |
| 00810832030232 | Balancing Application Instrument Kit |
| 00810832030225 | BRACKET NAV UNIT, KTIS |
| 00810832030218 | GUIDE,ALIGNMENT,KTIS |
| 00810832030201 | Tibial Tensor Instrument |
| 00810832030195 | Femoral Tensor Instrument |
| 00810832030058 | BASE, TRAY, 10x10, KTIS |
| 00858704006800 | KneeAlign 2 Instrument Kit |
| 00858704006510 | Button Cap, Black |
| 00858704006503 | Button Cap, White |
| 00858704006480 | Femoral Drill Guide, Neutral |
| 00858704006459 | Threaded Pin, Headless, 65mm |
| 00858704006442 | Threaded Pin, Headed, 46mm |
| 00858704006435 | Pin Driver, Tri-Flat, 3.2mm |
| 00858704006428 | Pin Driver |
| 00858704006411 | KneeAlign 2 Instrument Tray Base |
| 00858704006404 | KneeAlign 2 Inner Tray |
| 00858704006398 | Instrument Tray Lid |
| 00858704006381 | KneeAlign 2 Instrument Tray Base |
| 00858704006374 | 2.5mm Ball Driver |
| 00858704006367 | KneeAlign 2 Mounting Bracket |
| 00858704006343 | Distal Guide Assembly |
| 00858704006336 | MicroBlock Assembly |
| 00858704006329 | Universal Tibial Cutting Block |
| 00858704006312 | Reversed Tibial Cutting Block, Right |
| 00858704006305 | Reversed Tibial Cutting Block, Left |
| 00858704006299 | KneeAlign 2 Tibial Jig Body |
| 00858704006282 | KneeAlign 2 Tibial Jig Body, Streamlined |
| 00858704006275 | KneeAlign 2 Tibial Jig Body |
| 00858704006268 | Calf Strap |
| 00858704006251 | Extended Tibial Cutting Block, Right |
| 00858704006244 | Extended Tibial Cutting Block, Left |
| 00858704006237 | Adjustable Resection Stylus |
| 00858704006220 | Shin Spacer |
| 00858704006213 | Resection Stylus (4-8mm) |
| 00858704006206 | Resection Stylus (4-8mm) |
| 00858704006190 | Tibial Cutting Block, Right |
| 00858704006183 | Tibial Cutting Block, Right |
| 00858704006176 | Malleolar Probe, Curved |
| 00858704006169 | Malleolar Probe, Curved |
| 00858704006152 | Malleolar Probe |
| 00858704006145 | Malleolar Probe |
| 00858704006138 | Ankle Tube |
| 00858704006121 | Ankle Tube |
| 00858704006114 | Midline Probe |
| 00858704006107 | Midline Probe |
| 00858704006091 | Tibial Cutting Block, Left |