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Reliance Cervical IBF System

by Reliance Medical Systems, LLC 6 variants

510(k) K131429

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 NumberK131429 Date23 Sep 2013ClearedStatusActive

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  • Withdrawn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
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
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 Reliance Cervical IBF System is an intervertebral body fusion device designed for use in the cervical spine. It is indicated for the treatment of cervical degenerative disc disease at one level from C3 to T1 in patients who have undergone six weeks of non-operative treatment.

This device is regulated as an FDA Class 2 medical device under regulation number 888.3080. It has received FDA 510(k) clearance for clinical use as a spinal intervertebral body fixation orthosis.

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