FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
APTUS Wrist Arthrodesis Plates
K Number: K192297
·
Decision Nov 8, 2019
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
20
Review Days
77
Basic Information
- Device Name
- APTUS Wrist Arthrodesis Plates
- K Number
- K192297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medartis AG
- Date Received
- August 23, 2019
- Decision Date
- November 8, 2019
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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|---|---|---|---|
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