The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Titanium Interference Screws.
| Device ID | K202662 |
| 510k Number | K202662 |
| Device Name: | Parcus Titanium Interference Screws |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical, LLC 6423 Parkland Drive Sarasota, FL 34243 |
| Contact | Alejandra Anderson |
| Correspondent | Alejandra Anderson 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 | 2020-09-14 |
| Decision Date | 2021-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342020015 | K202662 | 000 |
| 00816342020008 | K202662 | 000 |