Defect Measurement Tool

QHG · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4510

Classification

FDA Product Code: QHG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.4510
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.

Market data

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

Source

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