The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Symmetric Pds Plus Knotless Tissue Control Devices, Stratafix Spiral Pds Plus Knotless Tissue Control Devices, Stratafix Spiral Monocryl Plus Knotless Tissue Control Devices, Stratafix Spiral Monocryl Knotless Tissue Control Devices.
| Device ID | K182873 |
| 510k Number | K182873 |
| Device Name: | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 |
| Contact | Ariell Joiner |
| Correspondent | Ariell Joiner Ethicon, Inc. Route 22 West, P.O. 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 | Yes |
| Date Received | 2018-10-12 |
| Decision Date | 2019-01-10 |
| Summary: | summary |