The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Graft Fixation System.
| Device ID | K090923 |
| 510k Number | K090923 |
| Device Name: | PARCUS GRAFT FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Contact | Barton Bracy |
| Correspondent | Barton Bracy PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-06-30 |
| Summary: | summary |