Multi-Drive Interference Screw System
FDA 510(k) K200428 · Nvision Biomedical Technologies, Inc.
510(k) numberK200428
Submission
- Device name
- Multi-Drive Interference Screw System
- Applicant
- Nvision Biomedical Technologies, Inc.
San Antonio, TX, US - Received
- February 21, 2020
- Decision date
- November 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Multi-Drive Interference Screw System cleared by the FDA?
Multi-Drive Interference Screw System (K200428) received a 510(k) decision of Substantially Equivalent on November 10, 2020, 263 days after the submission was received.
What is the product code of K200428?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.