510(k) K173964
K173964 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "OVOMotion Shoulder Arthroplasty System". The FDA issued a decision of Substantially Equivalent on April 18, 2018. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2018
- Date Received
- December 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3690
- Review Panel
- OR
- Submission Type