The following data is part of a premarket notification filed by Tyber Medical, Llc. with the FDA for Tyber Medical Staple Fixation System (various).
| Device ID | K221947 |
| 510k Number | K221947 |
| Device Name: | Tyber Medical Staple Fixation System (various) |
| Classification | Staple, Fixation, Bone |
| Applicant | Tyber Medical, LLC. 83 South Commerce Way Suite 310 Bethlehem, PA 18017 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle Tyber Medical, LLC. 83 South Commerce Way Suite 310 Bethlehem, PA 18017 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-10-20 |