The following data is part of a premarket notification filed by Parcus Medical with the FDA for Parcus Slik Anchors.
| Device ID | K170327 |
| 510k Number | K170327 |
| Device Name: | Parcus SLiK Anchors |
| 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 | 2017-02-02 |
| Decision Date | 2017-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M685111690 | K170327 | 000 |
| 00816342023429 | K170327 | 000 |
| 00816342023412 | K170327 | 000 |
| 00816342023405 | K170327 | 000 |
| 00816342023382 | K170327 | 000 |
| 00816342023375 | K170327 | 000 |
| 00816342024051 | K170327 | 000 |
| 00816342024044 | K170327 | 000 |
| 00816342024037 | K170327 | 000 |
| 00816342024020 | K170327 | 000 |
| 00816342023399 | K170327 | 000 |
| 00816342024013 | K170327 | 000 |
| M685111680 | K170327 | 000 |
| M685111670 | K170327 | 000 |
| M685111660 | K170327 | 000 |
| M685111650 | K170327 | 000 |
| M685112630 | K170327 | 000 |
| M685112620 | K170327 | 000 |
| M685112610 | K170327 | 000 |
| M685112600 | K170327 | 000 |
| M685112590 | K170327 | 000 |
| 00816342024006 | K170327 | 000 |