510(k) K153215
K153215 is an FDA 510(k) premarket notification submitted by Custom Orthopaedic Solutions, Inc. for the device "SmartBase for Arthrex Glenoid IRIS". The FDA issued a decision of Substantially Equivalent on Feb 19, 2016. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Custom Orthopaedic Solutions, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 19, 2016
- Date Received
- Nov 5, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
- 510(k)