The following data is part of a premarket notification filed by Smith And Nephew, Inc. with the FDA for Microraptor Knotless Suture Anchor.
| Device ID | K181746 |
| 510k Number | K181746 |
| Device Name: | MICRORAPTOR Knotless Suture Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Smith And Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Katherine Marcaccio |
| Correspondent | Camille Black Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556722541 | K181746 | 000 |
| 00885556722534 | K181746 | 000 |
| 00885556722510 | K181746 | 000 |
| 00885556722527 | K181746 | 000 |