Internal Hinged Elbow Fixator

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

Classification

FDA Product Code: OZI
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

The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 5

Source

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