510(k) K260975
K260975 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Libertas Acetabular Liners (Acetabular Liner)". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Maxx Orthopedics, Inc. has 25 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2026
- Date Received
- Mar 24, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type
- 510(k)