The following data is part of a premarket notification filed by Paragon 28 with the FDA for Monster Bite Screw System.
| Device ID | K153378 |
| 510k Number | K153378 |
| Device Name: | Monster BITE Screw System |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2015-12-21 |
| Summary: | summary |