FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
K Number: K132290
·
Decision Apr 10, 2014
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
21
Applicant Total
26
Review Days
261
Basic Information
- Device Name
- SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
- K Number
- K132290
- 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
- July 23, 2013
- Decision Date
- April 10, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PBF), ordered by most recent decision date.
CORIOGRAPH Pre-Op Planning and Modeling Services
FDA 510(k)
FDA Class 2
·Orthopedic
MedCAD® AccuStride System
FDA 510(k)
FDA Class 2
·Orthopedic
Newclip Patient-matched instrumentation non sterile PSI
FDA 510(k)
FDA Class 2
·Orthopedic
Newclip Patient-matched instrumentation non sterile PSI
FDA 510(k)
FDA Class 2
·Orthopedic
CORIOGRAPH Knee Pre-Op Plan
FDA 510(k)
FDA Class 2
·Orthopedic
Fine Osteotomy
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by MATERIALISE N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Aug 10, 2015 | Substantially Equivalent |
| K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER | May 22, 2014 | Substantially Equivalent |
| K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES | Apr 2, 2014 | Substantially Equivalent |
| K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA | Feb 25, 2014 | Substantially Equivalent |
| K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES | Sep 27, 2013 | Substantially Equivalent |
| K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM | Dec 5, 2012 | Substantially Equivalent |
| K112389 | SURGICASE CONNECT, SURGICASE GUIDE | Jul 20, 2012 | Substantially Equivalent |
| K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | Jun 15, 2012 | Substantially Equivalent |
| K113599 | SURGICASE CONNECT | Apr 27, 2012 | Substantially Equivalent |
| K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE | Apr 2, 2012 | Substantially Equivalent |