510(k) K191708
K191708 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head". The FDA issued a decision of Substantially Equivalent on Aug 14, 2020. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Signature Orthopaedics Pty, Ltd. has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2020
- Date Received
- Jun 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type
- 510(k)