The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Sniper Staple System.
| Device ID | K162354 |
| 510k Number | K162354 |
| Device Name: | Sniper Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | TRILLIANT SURGICAL LTD 6721 Portwest Dr. Suite 160 Houston, TX 77024 |
| Contact | Jon Olson |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812926027517 | K162354 | 000 |
| 00812926027500 | K162354 | 000 |