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 |