K191287 is an FDA 510(k) clearance for the OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Davol Inc., Subsidiary of C.R. Bard (Warwick, US). The FDA issued a Cleared decision on July 16, 2019, 64 days after receiving the submission on May 13, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K191287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2019 |
| Decision Date | July 16, 2019 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW - Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |