The following data is part of a premarket notification filed by Trilliant Surgical, Ltd with the FDA for Minimally Invasive Bunion Plating System.
| Device ID | K172178 |
| 510k Number | K172178 |
| Device Name: | Minimally Invasive Bunion Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Trilliant Surgical, LTD 6721 Portwest Drive, Suite 160 Houston, TX 77024 |
| Contact | Jonathan Olson |
| Correspondent | Jonathan Olson Trilliant Surgical, LTD 6721 Portwest Drive, Suite 160 Houston, TX 77024 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926027715 | K172178 | 000 |
| 00812926027708 | K172178 | 000 |