510(k) clearance
APEX 3D S Diamond Tibia
- 510(k) number
- K261120
- Applicant
- Paragon 28, Inc.
- Decision date
- Oct 7, 2026
- Date received
- Apr 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HSN
- Device type
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3110
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Englewood, CO, US