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JMS Cervical Traction Device/Halo Device

by Jerome Medical

510(k) K882877

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882877 Date30 Sep 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JEC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The JMS Cervical Traction Device/Halo Device is a component of a traction system used in orthopedic applications. It is classified as a Class II medical device under FDA regulation 888.3040.

The device received traditional 510(k) clearance (K882877) from the FDA on September 30, 1988, and was found substantially equivalent to a predicate device. It is manufactured by Jerome Medical and is intended for use in orthopedic settings as part of a cervical traction or halo fixation system.

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