The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Invisiknot Ankle Syndesmosis Repair Kit.
| Device ID | K162996 |
| 510k Number | K162996 |
| Device Name: | INVISIKNOT Ankle Syndesmosis Repair Kit |
| Classification | Washer, Bolt Nut |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Gregory Neal |
| Correspondent | Gregory Neal SMITH & NEPHEW, INC. 150 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556640227 | K162996 | 000 |