Product areas
FDA product code distribution
Kalitec Direct, LLC Doing Business AS Kalitec Medical
Country / Region:United States (US)
510(k) submissions
1
Filtered: OLO
Latest clearance
2023-12-13
Product codes
1
OLO
Cited as predicate
0
510(k) submissions
1 total · filtered by OLO
Showing 1–1
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K232572 | Kalitec Navigated Instrument System | OLO | Class 2 | 2023-12-13 |
Company profile
- Canonical name
- Kalitec Direct, LLC Doing Business AS Kalitec Medical
- Country / Region
- United States(US)
- Address
- 618 E. S. St., Suite 500 Orlando, FL 32801
Predicate manufacturers
Companies whose devices this company cited as predicates
No predicate manufacturers found
This company has not cited predicate devices with known manufacturers yet
Citing manufacturers
Companies that cited this company's devices as predicates
No citing manufacturers yet
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