Flex-Thread™ Distal Fibula Lntramedullary Nail System
Rod, Fixation, Intramedullary And Accessories
Flower Orthopedics Corporation DBA Conventus Flower
The following data is part of a premarket notification filed by Flower Orthopedics Corporation Dba Conventus Flower with the FDA for Flex-thread™ Distal Fibula Lntramedullary Nail System.
Pre-market Notification Details
| Device ID | K212030 |
| 510k Number | K212030 |
| Device Name: | Flex-Thread™ Distal Fibula Lntramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Flower Orthopedics Corporation DBA Conventus Flower 100 Witmer Road Horsham, PA 19044 |
| Contact | Amanda Pentecost |
| Correspondent | Amanda Pentecost Flower Orthopedics Corporation DBA Conventus Flower 100 Witmer Road Horsham, PA 19044 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-29 |
| Decision Date | 2021-07-23 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840118116640 | K212030 | 000 |
| 00840118116657 | K212030 | 000 |
Trademark Results [Flex-Thread]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEX-THREAD 88264445 not registered Live/Pending |
Intrafuse, LLC 2019-01-16 |
 FLEX-THREAD 86713909 not registered Dead/Abandoned |
Intrafuse, LLC 2015-08-04 |
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