The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Actiflip Naked, Actiflip Cinch, Actiflip Whip, Gfs Ultimate Hip.
| Device ID | K192750 |
| 510k Number | K192750 |
| Device Name: | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical, LLC 6423 Parkland Dr Sarasota, FL 34243 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts Parcus Medical, LLC 6423 Parkland Dr 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 | 2019-09-30 |
| Decision Date | 2020-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342024952 | K192750 | 000 |
| 00816342024518 | K192750 | 000 |
| 00816342023979 | K192750 | 000 |
| 00816342023962 | K192750 | 000 |