FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Acetabular Cup Orientation System
K Number: K150780
·
Decision Oct 27, 2015
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
61
Review Days
216
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Basic Information
- Device Name
- Acetabular Cup Orientation System
- K Number
- K150780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Materialise NV
- Date Received
- March 25, 2015
- Decision Date
- October 27, 2015
- Product Code
- PLW
- 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 |
|---|---|---|---|
| PLW | Acetabular Cup Orientation System | FDA class 2 | Orthopedic |
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