The following data is part of a premarket notification filed by Trilliant Surgical with the FDA for Two-step Implant System.
| Device ID | K181898 |
| 510k Number | K181898 |
| Device Name: | Two-Step Implant System |
| Classification | Screw, Fixation, Bone |
| Applicant | Trilliant Surgical 727 N Shepherd Dr. STE 100 Houston, TX 77007 |
| Contact | Jon Olson |
| Correspondent | Jon Olson Trilliant Surgical 727 N Shepherd Dr. STE 100 Houston, TX 77007 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2018-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926028750 | K181898 | 000 |
| 00812926028743 | K181898 | 000 |
| 00812926028736 | K181898 | 000 |
| 00812926028729 | K181898 | 000 |
| 00812926028712 | K181898 | 000 |
| 00812926028705 | K181898 | 000 |
| 00812926028699 | K181898 | 000 |
| 00812926029610 | K181898 | 000 |