The following data is part of a premarket notification filed by Parcus Medical Llc. with the FDA for Actiflip.
| Device ID | K212739 |
| 510k Number | K212739 |
| Device Name: | ActiFlip |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical LLC. 6423 Parkland Drive Sarasota, FL 34243 |
| Contact | Calen Souther |
| Correspondent | Calen Souther Parcus Medical LLC. 6423 Parkland Drive Sarasota, FL 34243 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2021-10-06 |