The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Healicoil Suture Anchor With Regenesorb.
| Device ID | K123393 |
| 510k Number | K123393 |
| Device Name: | HEALICOIL SUTURE ANCHOR WITH REGENESORB |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Sue Dahlquist |
| Correspondent | Sue Dahlquist SMITH & NEPHEW, INC. 150 MINUTEMAN RD. 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 | 2012-11-02 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554031713 | K123393 | 000 |
| 00885554031706 | K123393 | 000 |
| 00885554031430 | K123393 | 000 |
| 00885554031423 | K123393 | 000 |
| 00885554031409 | K123393 | 000 |
| 00885554031393 | K123393 | 000 |