FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AGILON® XO Shoulder Replacement System
K Number: K191433
·
Decision Nov 12, 2020
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
70
Applicant Total
20
Review Days
533
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Basic Information
- Device Name
- AGILON® XO Shoulder Replacement System
- K Number
- K191433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3690
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantcast GmbH
- Date Received
- May 29, 2019
- Decision Date
- November 12, 2020
- Product Code
- HSD
- 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 |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | FDA class 2 | Orthopedic |
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