The following data is part of a premarket notification filed by Surgical Innovation Associates, Inc. with the FDA for Polydioxanone Surgical Scaffold.
| Device ID | K181094 |
| 510k Number | K181094 |
| Device Name: | Polydioxanone Surgical Scaffold |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Surgical Innovation Associates, Inc. 965 West Chicago Ave Chicago, IL 60642 |
| Contact | Alexei Mlodinow |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2018-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000875905 | K181094 | 000 |
| 00860000875943 | K181094 | 000 |
| 00860000875929 | K181094 | 000 |