| Primary Device ID | 00840286860079 |
| NIH Device Record Key | 90a14df4-030a-4602-96b8-0c0d863d055f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Consensus Knee System |
| Version Model Number | 2800-0-2025 |
| Catalog Number | 2800-0-2025 |
| Company DUNS | 085976260 |
| Company Name | Shalby Advanced Technologies, Inc. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us | |
| Phone | +1(916)355-7100 |
| khansen@shalby.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840286860079 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
[00840286860079]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 00840286815444 | Tibial Insert, PCL Substituting, R, 5-6, 22mm |
| 00840286815437 | Tibial Insert, PCL Substituting, R, 5-6, 20mm |
| 00840286815420 | Tibial Insert, PCL Substituting, R, 5-6, 18mm |
| 00840286815413 | Tibial Insert, PCL Substituting, R, 5-6, 16mm |
| 00840286815406 | Tibial Insert, PCL Substituting, R, 5-6, 14mm |
| 00840286815390 | Tibial Insert, PCL Substituting, R, 5-6, 12mm |
| 00840286815383 | Tibial Insert, PCL Substituting, R, 5-6, 10mm |
| 00840286815376 | Tibial Insert, PCL Substituting, R, 3-4, 22mm |
| 00840286815369 | Tibial Insert, PCL Substituting, R, 3-4, 20mm |
| 00840286815352 | Tibial Insert, PCL Substituting, R, 3-4, 18mm |
| 00840286815345 | Tibial Insert, PCL Substituting, R, 3-4, 16mm |
| 00840286815338 | Tibial Insert, PCL Substituting, R, 3-4, 14mm |
| 00840286815321 | Tibial Insert, PCL Substituting, R, 3-4, 12mm |
| 00840286815314 | Tibial Insert, PCL Substituting, R, 3-4, 10mm |
| 00840286815307 | Tibial Insert, PCL Substituting, R, 1-2, 22mm |
| 00840286815291 | Tibial Insert, PCL Substituting, R, 1-2, 20mm |
| 00840286815284 | Tibial Insert, PCL Substituting, R, 1-2, 18mm |
| 00840286815277 | Tibial Insert, PCL Substituting, R, 1-2, 16mm |
| 00840286815260 | Tibial Insert, PCL Substituting, R, 1-2, 14mm |
| 00840286815253 | Tibial Insert, PCL Substituting, R, 1-2, 12mm |
| 00840286815246 | Tibial Insert, PCL Substituting, R, 1-2, 10mm |
| 00840286815239 | Tibial Insert, PCL Substituting, R, 0, 22mm |
| 00840286815222 | Tibial Insert, PCL Substituting, R, 0, 20mm |
| 00840286815215 | Tibial Insert, PCL Substituting, R, 0, 18mm |
| 00840286815208 | Tibial Insert, PCL Substituting, R, 0, 16mm |
| 00840286815192 | Tibial Insert, PCL Substituting, R, 0, 14mm |
| 00840286815185 | Tibial Insert, PCL Substituting, R, 0, 12mm |
| 00840286815178 | Tibial Insert, PCL Substituting, R, 0, 10mm |
| 00840286815161 | Tibial Insert, PCL Substituting, R, 5-6, 18mm |
| 00840286815154 | Tibial Insert, PCL Substituting, R, 5-6, 16mm |
| 00840286815147 | Tibial Insert, PCL Substituting, R, 5-6, 14mm |
| 00840286815130 | Tibial Insert, PCL Substituting, R, 5-6, 12mm |
| 00840286815123 | Tibial Insert, PCL Substituting, R, 5-6, 10mm |
| 00840286815116 | Tibial Insert, PCL Substituting, R, 3-4, 18mm |
| 00840286815109 | Tibial Insert, PCL Substituting, R, 3-4, 16mm |
| 00840286815093 | Tibial Insert, PCL Substituting, R, 3-4, 14mm |
| 00840286815086 | Tibial Insert, PCL Substituting, R, 3-4, 12mm |
| 00840286815079 | Tibial Insert, PCL Substituting, R, 3-4, 10mm |
| 00840286815062 | Tibial Insert, PCL Substituting, R, 1-2, 22mm |
| 00840286815055 | Tibial Insert, PCL Substituting, R, 1-2, 20mm |
| 00840286815048 | Tibial Insert, PCL Substituting, R, 1-2, 18mm |
| 00840286815031 | Tibial Insert, PCL Substituting, R, 1-2, 16mm |
| 00840286815024 | Tibial Insert, PCL Substituting, R, 1-2, 14mm |
| 00840286815017 | Tibial Insert, PCL Substituting, R, 1-2, 12mm |
| 00840286815000 | Tibial Insert, PCL Substituting, R, 1-2, 10mm |
| 00840286814997 | Tibial Insert, PCL Substituting, L, 5-6, 22mm |
| 00840286814980 | Tibial Insert, PCL Substituting, L, 5-6, 20mm |
| 00840286814973 | Tibial Insert, PCL Substituting, L, 5-6, 18mm |
| 00840286814966 | Tibial Insert, PCL Substituting, L, 5-6, 16mm |
| 00840286814959 | Tibial Insert, PCL Substituting, L, 5-6, 14mm |