Product code

QGQ: Bone indentation device

FDA product code · Class II · Orthopedic

Key facts

Product code QGQ
Device Bone indentation device
Device class Class II
Regulation number 888.1600
Review panel Orthopedic
Medical specialty Orthopedic
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition A bone indentation device is a device that measures resistance to indentation in bone.

At a glance

  • 1–9 510(k) clearances
  • 1–9 De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 1–9 UDI devices (GUDID)
  • None MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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