Nanova Interference Screw
FDA 510(k) K161174 · Nanova Biomaterials, Inc.
510(k) numberK161174
Submission
- Device name
- Nanova Interference Screw
- Applicant
- Nanova Biomaterials, Inc.
Columbia, MO, US - Received
- April 26, 2016
- Decision date
- November 3, 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 Nanova Interference Screw cleared by the FDA?
Nanova Interference Screw (K161174) received a 510(k) decision of Substantially Equivalent on November 3, 2016, 191 days after the submission was received.
What is the product code of K161174?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.