FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
K Number: K141989
·
Decision Nov 13, 2014
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
8
Review Days
114
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Basic Information
- Device Name
- MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
- K Number
- K141989
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mako Surgical Corporation
- Date Received
- July 22, 2014
- Decision Date
- November 13, 2014
- 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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Other Clearances by Mako Surgical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K142530 | Partial Knee Application (PKA) | Sep 16, 2015 | Substantially Equivalent |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mar 20, 2015 | Substantially Equivalent |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | Dec 10, 2013 | Substantially Equivalent |
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | Jun 6, 2012 | Substantially Equivalent |
| K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | Mar 1, 2012 | Substantially Equivalent |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | Jun 17, 2009 | Substantially Equivalent |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | Nov 28, 2008 | Substantially Equivalent |