INTRAFIX(TM) Advance Tibial Fastener System
FDA 510(k) K160804 · Medos International SARL
510(k) numberK160804
Submission
- Device name
- INTRAFIX(TM) Advance Tibial Fastener System
- Applicant
- Medos International SARL
Le Locle, CH - Received
- March 23, 2016
- Decision date
- July 19, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was INTRAFIX(TM) Advance Tibial Fastener System cleared by the FDA?
INTRAFIX(TM) Advance Tibial Fastener System (K160804) received a 510(k) decision of Substantially Equivalent on July 19, 2016, 118 days after the submission was received.
What is the product code of K160804?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.