The following data is part of a premarket notification filed by Paragon 28 with the FDA for Jaws(tm) Nitinol Staple System.
| Device ID | K170923 |
| 510k Number | K170923 |
| Device Name: | JAWS(TM) Nitinol Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | Paragon 28 4B Inverness Ct. E., STE 280 Englewood, CO 80112 |
| Contact | Frank S. Bono |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 -0566 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-29 |
| Decision Date | 2017-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795049926 | K170923 | 000 |
| 00889795114082 | K170923 | 000 |
| 00889795114143 | K170923 | 000 |
| 00889795049810 | K170923 | 000 |
| 00889795049827 | K170923 | 000 |
| 00889795049834 | K170923 | 000 |
| 00889795023650 | K170923 | 000 |
| 00889795023667 | K170923 | 000 |
| 00889795023674 | K170923 | 000 |
| 00889795023681 | K170923 | 000 |
| 00889795040305 | K170923 | 000 |
| 00889795040312 | K170923 | 000 |
| 00889795040336 | K170923 | 000 |
| 00889795130655 | K170923 | 000 |