510(k) K223227
K223227 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "MAVEN Patient-Specific Instrumentation". The FDA issued a decision of Substantially Equivalent on November 17, 2022. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2022
- Date Received
- October 18, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3110
- Review Panel
- OR
- Submission Type