The following data is part of a premarket notification filed by Smith And Nephew, Inc. with the FDA for Suturefix Curved Suture Anchor.
| Device ID | K163034 |
| 510k Number | K163034 |
| Device Name: | SUTUREFIX Curved Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Contact | Anne-marie Keefe |
| Correspondent | Anne-marie Keefe Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2016-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556737743 | K163034 | 000 |
| 00885556737262 | K163034 | 000 |
| 00885556754917 | K163034 | 000 |
| 00885556706466 | K163034 | 000 |
| 00885556706459 | K163034 | 000 |