510(k) K143184
K143184 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Evolve UniPolar Head". The FDA issued a decision of Substantially Equivalent on March 17, 2015. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2015
- Date Received
- November 5, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type