510(k) K231109
K231109 is an FDA 510(k) premarket notification submitted by Xerxes Arthopedix, LLC for the device "Xerxes Hip Stem". The FDA issued a decision of Substantially Equivalent on June 15, 2023. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2023
- Date Received
- April 19, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type