Product code OSE

Device name

Patient Specific Manual Navigation System

Medical specialty

Neurology

Device class

2

Regulation number

882.4560

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended for defining implant alignment relative to a patient's anatomy.

Source

FDA openFDA device classification dataset