Software For Diagnosis/Treatment

OSN · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030

Classification

FDA Product Code: OSN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3030
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

Market data

Cleared 510(k) submissions: 4
Registered establishments: 42

Source

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