510(k) K183194
K183194 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Eclipse Shoulder Prosthesis System". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code QHQ (Total Shoulder Arthroplasty System), a Class II device regulated under 21 CFR 888.3660. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2019
- Date Received
- November 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Total Shoulder Arthroplasty System
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
To treat pain and lack of function in the shoulder.