510(k) K123814
K123814 is an FDA 510(k) premarket notification submitted by Fx Solutions for the device "HUMELOCK II CEMENTED SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 2013. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Fx Solutions has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2013
- Date Received
- December 12, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3650
- Review Panel
- OR
- Submission Type