510(k) K192994
K192994 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Paragon 28 APEX 3D Total Ankle Replacement System". The FDA issued a decision of Substantially Equivalent on Jul 10, 2020. 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 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2020
- Date Received
- Oct 25, 2019
- Clearance Type
- Traditional
- 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
- 510(k)