Intraoperative Orthopedic Strain Sensor

QFP · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3090

Classification

FDA Product Code: QFP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3090
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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