QHG — Defect Measurement Tool Class II

FDA Device Classification

Classification Details

Product Code
QHG
Device Class
Class II
Regulation Number
888.4510
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201676intrinsic therapeuticsBarricaid Instrument TrayJuly 16, 2020