510(k) K151500
K151500 is an FDA 510(k) premarket notification submitted by Custom Orthopaedic Solutions for the device "Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)". The FDA issued a decision of Substantially Equivalent on Oct 5, 2015. 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 has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2015
- Date Received
- Jun 4, 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)