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Reliance Lumbar IBF System

by Reliance Medical Systems, LLC 5 variants

510(k) K183049

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 · Special NumberK183049 Date15 Feb 2019ClearedStatusActive

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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Lumbar IBF System is an intervertebral fusion device designed for use with autogenous bone graft to facilitate fusion between contiguous vertebral bodies in skeletally mature patients. It is a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable material, intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery.

The device is supplied in various sizes and is intended for use in the lumbar spine, typically in the treatment of degenerative disc disease. It is a single-use device and requires appropriate storage conditions. The Reliance Lumbar IBF System has received FDA 510(k) clearance with the K number K183049 and is classified under product code MAX as an Intervertebral Fusion Device With Bone Graft, Lumbar.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Reliance Lumbar IBF System used for?

    The Reliance Lumbar IBF System is an intervertebral fusion device designed to facilitate fusion between contiguous vertebral bodies in skeletally mature patients with degenerative disc disease. It is implanted into the space of an intervertebral disc that has been partially or totally removed during surgery.

  • How is the Reliance Lumbar IBF System supplied?

    The device is supplied in various sizes to accommodate different patient anatomies. It is a single-use device that requires appropriate storage conditions as specified by the manufacturer to maintain its integrity before implantation.

  • What material is the Reliance Lumbar IBF System made of?

    The Reliance Lumbar IBF System is made of non-bioabsorbable material and is designed as a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device. This structure allows for bone ingrowth while maintaining structural support for spinal fusion.

  • What is the regulatory status of the Reliance Lumbar IBF System?

    The Reliance Lumbar IBF System has received FDA 510(k) clearance with the K number K183049 and is classified under product code MAX as an Intervertebral Fusion Device With Bone Graft, Lumbar. This clearance indicates it is substantially equivalent to predicate devices on the market.