The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Gfs Ii And Gfs Mini, Gfs Naked, Gfs Ultimate, Gfs Btb, Atlas, Synd-ez Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, And Gfs Ultimate Hip.
| Device ID | K202259 |
| 510k Number | K202259 |
| Device Name: | Parcus GFS II And GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, And GFS Ultimate Hip |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical, LLC 6423 Parkland Drive Sarasota, FL 34243 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts 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 | 2020-08-10 |
| Decision Date | 2020-10-28 |