The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Twist 4 5mm Peek Suture Anchor, Parcus Twist 5.5mm Peek Suture Anchor & Parcus Triple Twist 5.5mm Peek Suture Anc.
| Device ID | K120942 |
| 510k Number | K120942 |
| Device Name: | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC |
| 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 | 2012-03-29 |
| Decision Date | 2012-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M68510525T0 | K120942 | 000 |
| 00816342023313 | K120942 | 000 |
| 00816342023320 | K120942 | 000 |
| 00816342023337 | K120942 | 000 |
| 00816342023344 | K120942 | 000 |
| 00816342023351 | K120942 | 000 |
| 00816342023368 | K120942 | 000 |
| 00816342021470 | K120942 | 000 |
| 00816342021487 | K120942 | 000 |
| 00816342025218 | K120942 | 000 |
| 00816342025201 | K120942 | 000 |
| 00816342023948 | K120942 | 000 |
| 00816342024174 | K120942 | 000 |
| 00816342024334 | K120942 | 000 |
| 00816342024341 | K120942 | 000 |
| 00816342024358 | K120942 | 000 |
| 00816342024365 | K120942 | 000 |
| 00816342025188 | K120942 | 000 |
| 00816342025195 | K120942 | 000 |
| 00816342021494 | K120942 | 000 |
| 00816342022323 | K120942 | 000 |
| M68510517T0 | K120942 | 000 |
| M68510517T1 | K120942 | 000 |
| M68510518T0 | K120942 | 000 |
| M685105210 | K120942 | 000 |
| M685105211 | K120942 | 000 |
| M685105220 | K120942 | 000 |
| M685105230 | K120942 | 000 |
| M68510524T0 | K120942 | 000 |
| M68510511T0 | K120942 | 000 |
| M685112860 | K120942 | 000 |
| 00816342022330 | K120942 | 000 |
| 00816342022347 | K120942 | 000 |
| 00816342022354 | K120942 | 000 |
| 00816342022484 | K120942 | 000 |
| 00816342023825 | K120942 | 000 |
| M685112830 | K120942 | 000 |
| M685112840 | K120942 | 000 |
| M685112850 | K120942 | 000 |
| 00816342023931 | K120942 | 000 |