FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Mako Shoulder Application (1.0)
K Number: K242373
·
Decision Nov 7, 2024
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
33
Review Days
90
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Basic Information
- Device Name
- Mako Shoulder Application (1.0)
- K Number
- K242373
- 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
- August 9, 2024
- Decision Date
- November 7, 2024
- 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 | ||
|---|---|---|---|
| K260222 | Mako Total Knee Application | Feb 25, 2026 | Substantially Equivalent |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Apr 25, 2025 | Substantially Equivalent |
| K243751 | Mako Total Hip Application 5.0 | Mar 5, 2025 | Substantially Equivalent |
| K241011 | Mako Total Knee Application | Jun 11, 2024 | Substantially Equivalent |
| K220930 | Restoris Multi-Compartmental Knee System | Jun 2, 2022 | Substantially Equivalent |
| K220459 | Mako Total Knee Application | Apr 15, 2022 | Substantially Equivalent |
| K193515 | Mako Total Knee Application | Jul 14, 2020 | Substantially Equivalent |
| K193128 | Mako Total Hip Application | Feb 2, 2020 | 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 |