510(k) K191698
K191698 is an FDA 510(k) premarket notification submitted by Fx Shoulder USA, Inc. for the device "TiN Coated Humeral Head". The FDA issued a decision of Substantially Equivalent on July 16, 2020. 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 Shoulder USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2020
- Date Received
- June 25, 2019
- 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