FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Total Knee Application (TKA)
K Number: K143752
·
Decision Aug 6, 2015
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
16
Review Days
218
Basic Information
- Device Name
- Total Knee Application (TKA)
- K Number
- K143752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAKO SURGICAL CORP.
- Date Received
- December 31, 2014
- Decision Date
- August 6, 2015
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | Feb 24, 2010 | Substantially Equivalent |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Sep 28, 2009 | Substantially Equivalent |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Jun 19, 2009 | Substantially Equivalent |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Nov 25, 2008 | Substantially Equivalent |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Oct 22, 2008 | Substantially Equivalent |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | Oct 15, 2008 | Substantially Equivalent |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Jun 20, 2008 | Substantially Equivalent |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | May 16, 2008 | Substantially Equivalent |