The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Twinfix Ultra Ha Suture Anchor.
| Device ID | K093844 |
| 510k Number | K093844 |
| Device Name: | SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Christina Flores |
| Correspondent | Christina Flores SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-15 |
| Decision Date | 2010-04-01 |
| Summary: | summary |