The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus 2.0mm / 2.5mm / 3.5mm Miti Titanium Suture Anchor.
| Device ID | K111000 |
| 510k Number | K111000 |
| Device Name: | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342021395 | K111000 | 000 |
| 00816342021364 | K111000 | 000 |
| 00816342021357 | K111000 | 000 |
| 00816342021340 | K111000 | 000 |
| 00816342022460 | K111000 | 000 |