510(k) K061564
K061564 is an FDA 510(k) premarket notification submitted by Portland Orthopaedics Pty. , Ltd. for the device "PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on September 1, 2006. 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. Portland Orthopaedics Pty. , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2006
- Date Received
- June 5, 2006
- 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