| Primary Device ID | 00840286855938 |
| NIH Device Record Key | 4845ecdf-7ca2-4470-96f4-3ec4f6a91105 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tahoe Unicompartmental Knee System |
| Version Model Number | 55075-00 |
| Catalog Number | 55075-00 |
| 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@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840286855938 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
[00840286855938]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 00840286846738 | TUKS, Alignment Rod, 6.4mm x 15" Length |
| 00840286846707 | Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 2" Long |
| 00840286855969 | TUKS, TIBIAL PREP GUIDE, DROP ROD ALIGNMENT, ASSY |
| 00840286855952 | Pin Puller, Assy |
| 00840286855945 | TUKS, Instrument Case 2, Assembly |
| 00840286855938 | TUKS, Instrument Case 1, Assembly |