The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Ankle Plating Set.
| Device ID | K133102 |
| 510k Number | K133102 |
| Device Name: | FLOWER ANKLE PLATING 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2013-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840118113106 | K133102 | 000 |
| 00840118109178 | K133102 | 000 |
| 00840118109161 | K133102 | 000 |
| 00840118109154 | K133102 | 000 |
| 00840118109147 | K133102 | 000 |
| 00840118109130 | K133102 | 000 |
| 00840118109123 | K133102 | 000 |
| 00840118109116 | K133102 | 000 |
| 00840118109109 | K133102 | 000 |
| 00840118109093 | K133102 | 000 |
| 00840118109086 | K133102 | 000 |
| 00840118109185 | K133102 | 000 |
| 00840118109192 | K133102 | 000 |
| 00840118111928 | K133102 | 000 |
| 00840118110808 | K133102 | 000 |
| 00840118110792 | K133102 | 000 |
| 00840118110785 | K133102 | 000 |
| 00840118110778 | K133102 | 000 |
| 00840118110150 | K133102 | 000 |
| 00840118110143 | K133102 | 000 |
| 00840118109222 | K133102 | 000 |
| 00840118109215 | K133102 | 000 |
| 00840118109208 | K133102 | 000 |
| 00840118109079 | K133102 | 000 |