The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Tenotac Soft Tissue Fixation System.
| Device ID | K182898 |
| 510k Number | K182898 |
| Device Name: | TenoTac Soft Tissue Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Paragon 28, Inc 4B Inverness Ct. E, STE 280 Englewood, CO 80112 |
| Contact | Eric Lintula |
| Correspondent | Eric Lintula Paragon 28, Inc 4B Inverness Ct. E, STE 280 Englewood, CO 80112 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-16 |
| Decision Date | 2019-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795053640 | K182898 | 000 |
| 00889795053633 | K182898 | 000 |
| 00889795053626 | K182898 | 000 |
| 00889795053602 | K182898 | 000 |
| 00889795053596 | K182898 | 000 |
| 00889795053589 | K182898 | 000 |
| 00889795053572 | K182898 | 000 |