FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Lateralized Glenosphere
K Number: K193175
·
Decision Aug 11, 2020
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
4
Review Days
267
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Basic Information
- Device Name
- Lateralized Glenosphere
- K Number
- K193175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta Inernational SA
- Date Received
- November 18, 2019
- Decision Date
- August 11, 2020
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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