510(k) K163081
K163081 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "40-42mm BiPolar Head and 22mm Femoral Head". The FDA issued a decision of Substantially Equivalent on January 29, 2018. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2018
- Date Received
- November 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3390
- Review Panel
- OR
- Submission Type