The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Knotless Ap Suture Anchors.
| Device ID | K192824 |
| 510k Number | K192824 |
| Device Name: | Parcus Knotless AP Suture Anchors |
| Classification | Fastener, Fixation, Biodegradable, 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-02 |
| Decision Date | 2019-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M685108040 | K192824 | 000 |
| M685108030 | K192824 | 000 |
| M685108020 | K192824 | 000 |
| 00816342024822 | K192824 | 000 |
| 00816342024815 | K192824 | 000 |
| 00816342024808 | K192824 | 000 |