K150670 is an FDA 510(k) clearance for the STRATAFIX Spiral PDS Plus Knotless Tissue Control Device. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 2, 2015, 108 days after receiving the submission on March 16, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K150670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2015 |
| Decision Date | July 02, 2015 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |