FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Mako Total Hip Application
K Number: K170593
·
Decision Apr 18, 2017
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
10
Review Days
49
Basic Information
- Device Name
- Mako Total Hip Application
- K Number
- K170593
- 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 Corp.
- Date Received
- February 28, 2017
- Decision Date
- April 18, 2017
- 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 Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K242373 | Mako Shoulder Application (1.0) | Nov 7, 2024 | Substantially Equivalent |
| K241011 | Mako Total Knee Application | Jun 11, 2024 | Substantially Equivalent |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Sep 24, 2019 | Substantially Equivalent |
| K172301 | Mako Partial Knee Application | Nov 2, 2017 | Substantially Equivalent |
| K172219 | Mako Total Knee Application | Sep 21, 2017 | Substantially Equivalent |
| K170891 | Mako Partial Knee Application | May 24, 2017 | Substantially Equivalent |
| K170584 | Mako Partial Knee Application | May 11, 2017 | Substantially Equivalent |
| K170581 | Mako Total Knee Application | May 11, 2017 | Substantially Equivalent |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | Jan 26, 2015 | Substantially Equivalent |