The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set.
| Device ID | K133930 |
| 510k Number | K133930 |
| Device Name: | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET |
| Classification | Plate, Fixation, Bone |
| Applicant | FLOWER ORTHOPEDICS CORPORATION 100 Witmer Rd Ste 280 Horsham, PA 19044 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett FLOWER ORTHOPEDICS CORPORATION 100 Witmer Rd Ste 280 Horsham, PA 19044 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840118115797 | K133930 | 000 |
| 00840118115650 | K133930 | 000 |
| 00840118115667 | K133930 | 000 |
| 00840118115674 | K133930 | 000 |
| 00840118115681 | K133930 | 000 |
| 00840118115698 | K133930 | 000 |
| 00840118115742 | K133930 | 000 |
| 00840118115759 | K133930 | 000 |
| 00840118115766 | K133930 | 000 |
| 00840118115773 | K133930 | 000 |
| 00840118115780 | K133930 | 000 |
| 00840118115643 | K133930 | 000 |