K122487 is an FDA 510(k) clearance for the BIOFIBER SYTURE. 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 September 17, 2012, 33 days after receiving the submission on August 15, 2012.
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 | K122487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2012 |
| Decision Date | September 17, 2012 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| 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. |