PointCloud
GUDID TKRL0000FD945
UNIKO PointCloud™ Knee Instrument Kit Left
Unik Orthopedics Inc.
Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit Total knee prosthesis implantation guide-instrument kit| Primary Device ID | TKRL0000FD945 |
| NIH Device Record Key | 14273767-1213-441b-831b-50c27e6751f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PointCloud |
| Version Model Number | UKI0101-L |
| Company DUNS | 118205691 |
| Company Name | Unik Orthopedics 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | TKRL0000FD945 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193312
FDA Product Code
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
[TKRL0000FD945]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-22 |
On-Brand Devices [PointCloud]
| TKRR0000LID65 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000LI745 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000LI105 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000LD2D5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000LB3B5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000L6855 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000L6265 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000L5K05 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000L4F85 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000FK065 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000FI7I5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000FF8D5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000FF295 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000FB3F5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000F4995 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000F17L5 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000DFL65 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRR0000DF825 | UNIKO PointCloud™ Knee Instrument Kit Right |
| TKRL0000LL595 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000LK015 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000LF225 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000LDF45 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000LBI35 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000L6F15 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000L55K5 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000L3D05 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FLK35 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FKD15 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FK6D5 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FID95 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FI105 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FFLL5 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FDFI5 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FD945 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000FD355 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000F8845 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000F5635 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000F30I5 | UNIKO PointCloud™ Knee Instrument Kit Left |
| TKRL0000F1L25 | UNIKO PointCloud™ Knee Instrument Kit Left |
Trademark Results [PointCloud]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POINTCLOUD 85589655 4441575 Live/Registered |
13th Lab AB 2012-04-05 |
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