Product code OJP

Device name

Orthopedic Computer Controlled Surgical 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

Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

Source

FDA openFDA device classification dataset