Cleared Traditional

JMS CERVICAL TRACTION DEVICE/HALO DEVICE

K882877 · Jerome Medical · Orthopedic
Sep 1988
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K882877 is an FDA 510(k) clearance for the JMS CERVICAL TRACTION DEVICE/HALO DEVICE, 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 September 30, 1988, 81 days after receiving the submission on July 11, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K882877 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1988
Decision Date September 30, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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

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