The following data is part of a premarket notification filed by Pivot Medical with the FDA for Nanotack Suture Anchor 1.4mm.
| Device ID | K110473 |
| 510k Number | K110473 |
| Device Name: | NANOTACK SUTURE ANCHOR 1.4MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PIVOT MEDICAL 247 HUMBOLDT CT. Sunnyvale, CA 94089 |
| Contact | Jon Cook |
| Correspondent | Jon Cook PIVOT MEDICAL 247 HUMBOLDT CT. Sunnyvale, CA 94089 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2011-05-25 |
| Summary: | summary |