The following data is part of a premarket notification filed by Trilliant Surgical with the FDA for Sniper Staple System, Non-sterile.
| Device ID | K172405 |
| 510k Number | K172405 |
| Device Name: | SNIPER STAPLE SYSTEM, NON-STERILE |
| Classification | Staple, Fixation, Bone |
| Applicant | Trilliant Surgical 6721 Portwest Drive Houston, TX 77024 |
| Contact | Jon Olson |
| Correspondent | Jon Olson Trilliant Surgical 6721 Portwest Drive, Suite 160 Houston, TX 77024 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2017-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926028620 | K172405 | 000 |
| 00812926028224 | K172405 | 000 |
| 00812926028231 | K172405 | 000 |
| 00812926028248 | K172405 | 000 |
| 00812926028255 | K172405 | 000 |
| 00812926028262 | K172405 | 000 |
| 00812926028279 | K172405 | 000 |
| 00812926028606 | K172405 | 000 |
| 00812926028613 | K172405 | 000 |
| 00812926028217 | K172405 | 000 |