The following data is part of a premarket notification filed by Paragon 28,inc. with the FDA for Tenodesis Screw System.
| Device ID | K183690 |
| 510k Number | K183690 |
| Device Name: | Tenodesis Screw 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 | 2018-12-31 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795107527 | K183690 | 000 |
| 00889795128294 | K183690 | 000 |
| 00889795128287 | K183690 | 000 |
| 00889795128270 | K183690 | 000 |
| 00889795128263 | K183690 | 000 |
| 00889795128256 | K183690 | 000 |
| 00889795128249 | K183690 | 000 |
| 00889795128232 | K183690 | 000 |
| 00889795128225 | K183690 | 000 |
| 00889795128218 | K183690 | 000 |
| 00889795128300 | K183690 | 000 |
| 00889795128317 | K183690 | 000 |
| 00889795128324 | K183690 | 000 |
| 00889795107510 | K183690 | 000 |
| 00889795106315 | K183690 | 000 |
| 00889795128393 | K183690 | 000 |
| 00889795128386 | K183690 | 000 |
| 00889795128379 | K183690 | 000 |
| 00889795128362 | K183690 | 000 |
| 00889795128355 | K183690 | 000 |
| 00889795128348 | K183690 | 000 |
| 00889795128331 | K183690 | 000 |
| 00889795128201 | K183690 | 000 |