The following data is part of a premarket notification filed by Pivot Medical Inc. with the FDA for Nanotack Suture Anchor 1.4mm With Flex Inserter.
| Device ID | K130351 |
| 510k Number | K130351 |
| Device Name: | NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PIVOT MEDICAL INC. 247 HUMBOLDT CT Sunnyvale, CA 94089 -0000 |
| Contact | Jon Cook |
| Correspondent | Jon Cook PIVOT MEDICAL INC. 247 HUMBOLDT CT Sunnyvale, CA 94089 -0000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-12 |
| Decision Date | 2013-03-14 |
| Summary: | summary |