510(k) K182943
K182943 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, LLC for the device "VERTEX Nitinol Staple System". The FDA issued a decision of Substantially Equivalent on Apr 4, 2019. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Nvision Biomedical Technologies, LLC has 38 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 2019
- Date Received
- Oct 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)