510(k) K193280
K193280 is an FDA 510(k) premarket notification submitted by Medcad for the device "MedCAD® AccuPlate® Patient-Specific Plate". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Medcad has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2021
- Date Received
- November 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type