The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Spiral Monocryl Knotless Tissue Control Device, Stratafix Spiral Monocryl Plus Knotless Tissue Control Device.
| Device ID | K151200 |
| 510k Number | K151200 |
| Device Name: | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-05-05 |
| Decision Date | 2015-08-13 |
| Summary: | summary |