The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Spiral Pds Plus Knotless Tissue Control Device.
| Device ID | K150670 |
| 510k Number | K150670 |
| Device Name: | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | ETHICON, INC. ROUTE 22 WEST, PO BOX 151 Somerville, NJ 08876 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall ETHICON, INC. ROUTE 22 WEST, PO BOX 151 Somerville, NJ 08876 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-07-02 |
| Summary: | summary |