OSE — Patient Specific Manual Navigation System Class II
FDA product code OSE covers "Patient Specific Manual Navigation System", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- OSE
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
Definition
Intended for defining implant alignment relative to a patient's anatomy.