The following data is part of a premarket notification filed by Parcus Medical with the FDA for Parcus Slik Fix Screw.
| Device ID | K170877 |
| 510k Number | K170877 |
| Device Name: | Parcus SLiK Fix Screw |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical 6423 Parkland Dr Sarasota, FL 34243 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts Parcus Medical 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 | 2017-03-24 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342023481 | K170877 | 000 |
| 00816342023474 | K170877 | 000 |
| 00816342023467 | K170877 | 000 |
| 00816342023450 | K170877 | 000 |
| 00816342023443 | K170877 | 000 |
| 00816342023436 | K170877 | 000 |