The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus 35 Knotless Peek Cf Push-in Suture Anchors, Parcus 45 Knotless Peek Cf Push-in Suture Anchors.
| Device ID | K113730 |
| 510k Number | K113730 |
| Device Name: | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342021166 | K113730 | 000 |
| 00816342024136 | K113730 | 000 |
| 00816342023788 | K113730 | 000 |
| 00816342021173 | K113730 | 000 |
| 00816342021159 | K113730 | 000 |
| 00816342021142 | K113730 | 000 |