The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Upper Extremity Plating Set.
| Device ID | K142306 |
| 510k Number | K142306 |
| Device Name: | Flower Upper Extremity Plating Set |
| Classification | Plate, Fixation, Bone |
| Applicant | Flower Orthopedics Corporation 100 Witmer Road, Suite 280 Horsham, PA 19044 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett Flower Orthopedics Corporation 100 Witmer Road, Suite 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 | 2014-08-19 |
| Decision Date | 2014-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840118111843 | K142306 | 000 |
| 00840118104746 | K142306 | 000 |
| 00840118104753 | K142306 | 000 |
| 00840118111737 | K142306 | 000 |
| 00840118111744 | K142306 | 000 |
| 00840118111751 | K142306 | 000 |
| 00840118111768 | K142306 | 000 |
| 00840118111775 | K142306 | 000 |
| 00840118111782 | K142306 | 000 |
| 00840118111799 | K142306 | 000 |
| 00840118111805 | K142306 | 000 |
| 00840118111812 | K142306 | 000 |
| 00840118111829 | K142306 | 000 |
| 00840118111836 | K142306 | 000 |
| 00840118103862 | K142306 | 000 |