Flex-Thread Fibula Pin System
FDA 510(k) K172943 · Intrafuse, LLC
510(k) numberK172943
Submission
- Device name
- Flex-Thread Fibula Pin System
- Applicant
- Intrafuse, LLC
Logan, UT, US - Received
- September 26, 2017
- Decision date
- October 30, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K163488 | Flex-Thread Clavicle Pin SystemHSB · Traditional | 03/20/2017SE |
Questions and answers
When was Flex-Thread Fibula Pin System cleared by the FDA?
Flex-Thread Fibula Pin System (K172943) received a 510(k) decision of Substantially Equivalent on October 30, 2017, 34 days after the submission was received.
What is the product code of K172943?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.