FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
SURGICASE CONNECT, SURGICASE GUIDE
K Number: K112389
·
Decision Jul 20, 2012
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
21
Applicant Total
26
Review Days
337
Basic Information
- Device Name
- SURGICASE CONNECT, SURGICASE GUIDE
- K Number
- K112389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MATERIALISE N.V.
- Date Received
- August 18, 2011
- Decision Date
- July 20, 2012
- 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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