Electronic Depth Gauge

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

Classification

FDA Product Code: OOL
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: N
Third-party review: N

Definition

For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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