Cleared Traditional

SYSTEM III HALO RING

K930153 · Jerome Medical · Orthopedic
Aug 1993
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K930153 is an FDA 510(k) clearance for the SYSTEM III HALO RING, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on August 6, 1993, 206 days after receiving the submission on January 12, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K930153 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1993
Decision Date August 06, 1993
Days to Decision 206 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JEC — Component, Traction, Invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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