The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Synd-ez Ti.
| Device ID | K191783 |
| 510k Number | K191783 |
| Device Name: | Parcus Synd-EZ Ti |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M685112230 | K191783 | 000 |
| 00816342024402 | K191783 | 000 |
| 00816342025003 | K191783 | 000 |