510(k) K240783
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems by
Smith & Nephew, Inc.
— Product Code JDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2024
- Date Received
- March 21, 2024
- 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