| Primary Device ID | 08800036800931 |
| NIH Device Record Key | 2ad83764-3ad5-426e-a11d-0eb8328dbd3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CentLoc Total Knee System |
| Version Model Number | 7122-5276 |
| Catalog Number | 7122-5276 |
| Company DUNS | 694670830 |
| Company Name | RootLoc Co., Ltd. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800036800931 [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 | 2019-09-27 |
| Device Publish Date | 2019-09-19 |
| 08800036800337 | CentLoc Femoral component PS type Right Size9 |
| 08800036800320 | CentLoc Femoral component PS type Right Size9-1 |
| 08800036800313 | CentLoc Femoral component PS type Right Size8 |
| 08800036800306 | CentLoc Femoral component PS type Right Size8-3 |
| 08800036800290 | CentLoc Femoral component PS type Right Size8-2 |
| 08800036800283 | CentLoc Femoral component PS type Right Size8-1 |
| 08800036800276 | CentLoc Femoral component PS type Right Size7 |
| 08800036800269 | CentLoc Femoral component PS type Right Size7-1 |
| 08800036800252 | CentLoc Femoral component PS type Right Size6 |
| 08800036800245 | CentLoc Femoral component PS type Right Size6-1 |
| 08800036800238 | CentLoc Femoral component PS type Right Size6N |
| 08800036800221 | CentLoc Femoral component PS type Right Size5 |
| 08800036800214 | CentLoc Femoral component PS type Right Size4-1 |
| 08800036800207 | CentLoc Femoral component PS type Right Size4 |
| 08800036800191 | CentLoc Femoral component PS type Right Size3 |
| 08800036800184 | CentLoc Femoral component PS type Right Size2 |
| 08800036800177 | CentLoc Femoral component PS type Right Size1 |
| 08800036800160 | CentLoc Femoral component PS type Left Size9 |
| 08800036800153 | CentLoc Femoral component PS type Left Size9-1 |
| 08800036800146 | CentLoc Femoral component PS type Left Size8 |
| 08800036800139 | CentLoc Femoral component PS type Left Size8-3 |
| 08800036800122 | CentLoc Femoral component PS type Left Size8-2 |
| 08800036800115 | CentLoc Femoral component PS type Left Size8-1 |
| 08800036800108 | CentLoc Femoral component PS type Left Size7 |
| 08800036800092 | CentLoc Femoral component PS type Left Size7-1 |
| 08800036800085 | CentLoc Femoral component PS type Left Size6 |
| 08800036800078 | CentLoc Femoral component PS type Left Size6-1 |
| 08800036800061 | CentLoc Femoral component PS type Left Size6N |
| 08800036800054 | CentLoc Femoral component PS type Left Size5 |
| 08800036800047 | CentLoc Femoral component PS type Left Size4-1 |
| 08800036800030 | CentLoc Femoral component PS type Left Size4 |
| 08800036800023 | CentLoc Femoral component PS type Left Size3 |
| 08800036800016 | CentLoc Femoral component PS type Left Size 2 |
| 08800036800009 | CentLoc Femoral component PS type Left Size1 |
| 08800036800825 | CentLoc Tibial tray component CCM Size9 |
| 08800036800818 | CentLoc Tibial tray component CCM Size8-4 |
| 08800036800801 | CentLoc Tibial tray component CCM Size8-3 |
| 08800036800795 | CentLoc Tibial tray component CCM Size8-2 |
| 08800036800788 | CentLoc Tibial tray component CCM Size8-1 |
| 08800036800771 | CentLoc Tibial tray component CCM Size8 |
| 08800036800764 | CentLoc Tibial tray component CCM Size7 |
| 08800036800757 | CentLoc Tibial tray component CCM Size6-1 |
| 08800036800740 | CentLoc Tibial tray component CCM Size6 |
| 08800036800733 | CentLoc Tibial tray component CCM Size5 |
| 08800036800726 | CentLoc Tibial tray component CCM Size4-1 |
| 08800036800719 | CentLoc Tibial tray component CCM Size4 |
| 08800036800702 | CentLoc Tibial tray component CCM Size3 |
| 08800036800696 | CentLoc Tibial tray component CCM Size2 |
| 08800036800689 | CentLoc Tibial tray component CCM Size1 |
| 08800036800672 | CentLoc Femoral component CR type Right Size9 |