The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Nitinol Staple System.
| Device ID | K190166 |
| 510k Number | K190166 |
| Device Name: | TriMed Nitinol Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355 |
| Contact | David Medoff |
| Correspondent | Jean Asquith Jean Asquith 4221 Lost Oasis Hollow Austin, TX 78739 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-31 |
| Decision Date | 2019-07-01 |