FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
K Number: K113829
·
Decision Apr 2, 2012
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
26
Review Days
97
Basic Information
- Device Name
- ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
- K Number
- K113829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MATERIALISE N.V.
- Date Received
- December 27, 2011
- Decision Date
- April 2, 2012
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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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 |
| K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | Apr 10, 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 |