Flex-Thread Distal Fibula lntramedullary Nail System
Summary
Flower Orthopedics Corporation Dba Conventus Flower received 510(k) clearance for Flex-Thread Distal Fibula lntramedullary Nail System, a HSB device. Cleared on 2021-07-23.
Details
Source
510(k) Clearance
External ID
K212030
Action Date
2021-07-23
Status
Special
Category
device
Product Code
HSB
Product Description
Flex-Thread Distal Fibula lntramedullary Nail System. Product code: HSB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Flower Orthopedics Corporation Dba Conventus Flower has received 2 total clearances in our database.
Flower Orthopedics Corporation Dba Conventus Flower has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Flower Orthopedics Corporation Dba Conventus Flower have FDA actions?
Flower Orthopedics Corporation Dba Conventus Flower has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212030" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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