The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Small And Medium Implant Set.
| Device ID | K131657 |
| 510k Number | K131657 |
| Device Name: | FLOWER SMALL AND MEDIUM IMPLANT SET |
| Classification | Plate, Fixation, Bone |
| Applicant | FLOWER ORTHOPEDICS CORPORATION 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan FLOWER ORTHOPEDICS CORPORATION 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2013-08-22 |
| Summary: | summary |