The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Suture Anchor Set.
| Device ID | K192949 |
| 510k Number | K192949 |
| Device Name: | Flower Suture Anchor Set |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Flower Orthopedics Corporation 100 Witmer Rd. Suite 280 Horsham, PA 19044 |
| Contact | Jessica Huang |
| Correspondent | Amanda Pentecost Hogan Lovells US LLP 100 Witmer Rd. Suite 280 Horsham, PA 19044 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2020-10-07 |