The following data is part of a premarket notification filed by Unik Orthopedics, Inc. with the FDA for Uniko Pointcloud™ Knee Instruments.
| Device ID | K193312 |
| 510k Number | K193312 |
| Device Name: | UNIKO PointCloud™ Knee Instruments |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Unik Orthopedics, Inc. 1701 Fortune Drive, Unit E San Jose, CA 95131 |
| Contact | Charlie Chi |
| Correspondent | Charlie Chi Unik Orthopedics, Inc. 1701 Fortune Drive, Unit E San Jose, CA 95131 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| TKRR0000LID65 | K193312 | 000 |
| TKRL0000LDF45 | K193312 | 000 |
| TKRL0000LBI35 | K193312 | 000 |
| TKRL0000L6F15 | K193312 | 000 |
| TKRL0000L55K5 | K193312 | 000 |
| TKRL0000L3D05 | K193312 | 000 |
| TKRL0000FLK35 | K193312 | 000 |
| TKRL0000FKD15 | K193312 | 000 |
| TKRL0000FK6D5 | K193312 | 000 |
| TKRL0000FID95 | K193312 | 000 |
| TKRL0000FI105 | K193312 | 000 |
| TKRL0000FFLL5 | K193312 | 000 |
| TKRL0000FDFI5 | K193312 | 000 |
| TKRL0000FD945 | K193312 | 000 |
| TKRL0000FD355 | K193312 | 000 |
| TKRL0000F8845 | K193312 | 000 |
| TKRL0000F5635 | K193312 | 000 |
| TKRL0000F30I5 | K193312 | 000 |
| TKRL0000LF225 | K193312 | 000 |
| TKRL0000LK015 | K193312 | 000 |
| TKRL0000LL595 | K193312 | 000 |
| TKRR0000LI745 | K193312 | 000 |
| TKRR0000LI105 | K193312 | 000 |
| TKRR0000LD2D5 | K193312 | 000 |
| TKRR0000LB3B5 | K193312 | 000 |
| TKRR0000L6855 | K193312 | 000 |
| TKRR0000L6265 | K193312 | 000 |
| TKRR0000L5K05 | K193312 | 000 |
| TKRR0000L4F85 | K193312 | 000 |
| TKRR0000FK065 | K193312 | 000 |
| TKRR0000FI7I5 | K193312 | 000 |
| TKRR0000FF8D5 | K193312 | 000 |
| TKRR0000FF295 | K193312 | 000 |
| TKRR0000FB3F5 | K193312 | 000 |
| TKRR0000F4995 | K193312 | 000 |
| TKRR0000F17L5 | K193312 | 000 |
| TKRR0000DFL65 | K193312 | 000 |
| TKRR0000DF825 | K193312 | 000 |
| TKRL0000F1L25 | K193312 | 000 |