FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
3D-Cut
K Number: K212237
·
Decision Nov 29, 2021
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- 3D-Cut
- K Number
- K212237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D-Side S.A.
- Date Received
- July 19, 2021
- Decision Date
- November 29, 2021
- Product Code
- PBF
- 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 |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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