OSE
- Product code
- OSE
- Device name
- Patient Specific Manual Navigation System
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
FDA classification definition
Intended for defining implant alignment relative to a patient's anatomy.
Official FDA classification page: OSE
Classification and pathway per current FDA publications. Data from openFDA (CC0).