510(k) K181340
K181340 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Cemented TSI Hip Stem". The FDA issued a decision of Substantially Equivalent on Feb 11, 2019. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Signature Orthopaedics Pty, Ltd. has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2019
- Date Received
- May 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type
- 510(k)