K130422 is an FDA 510(k) clearance for the PHANTOM FIBER BIOFIBER SUTURE. This device is classified as a Suture, Recombinant Technology (Class II - Special Controls, product code NWJ).
Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 4, 2013, 43 days after receiving the submission on February 20, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4494. Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation..
| 510(k) Number | K130422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2013 |
| Decision Date | April 04, 2013 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NWJ — Suture, Recombinant Technology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4494 |
| Definition | Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation. |