Orthopedic Stereotaxic Instrument

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

Classification

FDA Product Code: OLO
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

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Market data

Cleared 510(k) submissions: 423
Registered establishments: 380

Source

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