FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex Eclipse Shoulder Prosthesis System
K Number: K201542
·
Decision Jul 8, 2020
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
16
Applicant Total
36
Review Days
29
Basic Information
- Device Name
- Arthrex Eclipse Shoulder Prosthesis System
- K Number
- K201542
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- June 9, 2020
- Decision Date
- July 8, 2020
- Product Code
- PKC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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