Product areas
FDA product code distribution
Mako Surgical Corp.
Country / Region:United States (US)Website:mako.com
510(k) submissions
6
Filtered: OLO
Latest clearance
2026-02-25
Product codes
1
OLO
510(k) submissions
6 total · filtered by OLO
Showing 1–6
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K260222 | Mako Total Knee Application | OLO | Class 2 | 2026-02-25 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | OLO | Class 2 | 2025-04-25 |
| K243751 | Mako Total Hip Application 5.0 | OLO | Class 2 | 2025-03-05 |
| K242373 | Mako Shoulder Application (1.0) | OLO | Class 2 | 2024-11-07 |
| K241011 | Mako Total Knee Application | OLO | Class 2 | 2024-06-11 |
| K220459 | Mako Total Knee Application | OLO | Class 2 | 2022-04-15 |
Company profile
- Canonical name
- Mako Surgical Corp.
- Country / Region
- United States(US)
- Address
- 3365 Enterprise Ave. Weston, FL 33331
- Website
- mako.com
Predicate manufacturers
Companies whose devices this company cited as predicates
4 manufacturers
- 4
- 1
- 1
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
3 manufacturers
- 4
- 1
- 1