OSEClass II
Patient Specific Manual Navigation System
Neurology · 21 CFR 882.4560
Intended for defining implant alignment relative to a patient's anatomy.
MDR events1All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.