Orthopedic Computer Controlled Surgical System

OJP · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560

Classification

FDA Product Code: OJP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4560
Review panel: OR
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 4
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown