The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Healicoil Knotless Suture Anchors.
| Device ID | K193558 |
| 510k Number | K193558 |
| Device Name: | HEALICOIL Knotless Suture Anchors |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Camille Black |
| Correspondent | Camille Black Smith & 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 | 2019-12-23 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556767351 | K193558 | 000 |
| 00885556767337 | K193558 | 000 |
| 00885556767320 | K193558 | 000 |
| 00885556767146 | K193558 | 000 |