510(k) K201278
K201278 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "World Hip Stem, World Cup, World Liner". The FDA issued a decision of Substantially Equivalent on Sep 21, 2020. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Signature Orthopaedics Pty, Ltd. has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2020
- Date Received
- May 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)