Arthrex Eclipse Shoulder Prosthesis System
FDA 510(k) K183194 · Arthrex, Inc.
510(k) numberK183194
Submission
- Device name
- Arthrex Eclipse Shoulder Prosthesis System
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- November 19, 2018
- Decision date
- July 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHQ – Total Shoulder Arthroplasty System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
To treat pain and lack of function in the shoulder.
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Questions and answers
When was Arthrex Eclipse Shoulder Prosthesis System cleared by the FDA?
Arthrex Eclipse Shoulder Prosthesis System (K183194) received a 510(k) decision of Substantially Equivalent on July 26, 2019, 249 days after the submission was received.
What is the product code of K183194?
The FDA product code is QHQ – Total Shoulder Arthroplasty System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.