The following data is part of a premarket notification filed by Smith And Nephew, Inc with the FDA for Microraptor Regenesorb Suture Anchor.
| Device ID | K180361 |
| 510k Number | K180361 |
| Device Name: | MICRORAPTOR REGENESORB Suture Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Smith And Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Katherine Marcaccio |
| Correspondent | Katherine Marcaccio Smith And Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-09 |
| Decision Date | 2018-05-30 |
| Summary: | summary |