510(k) K181118

Reliance Lumbar IBF System by Reliance Medical Systems — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 9, 2019
Date Received: April 27, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Reliance Medical Systems

K202266 — Reliance Cervical IBF System (March 29, 2022)
K210874 — Reliance Spinal Screw System (May 13, 2021)
K183049 — Reliance Lumbar IBF System (February 15, 2019)
K180687 — Reliance Lumber IBF System (May 15, 2018)
K173283 — Reliance Lumbar IBF System (January 19, 2018)
K173102 — Reliance Cervical IBF System (December 29, 2017)
K172489 — Reliance Cervical IBF System (September 7, 2017)
K162066 — Reliance Spinal Screw System (December 2, 2016)
K160463 — Reliance Lumbar IBF System (May 20, 2016)
K152131 — Reliance Spinal Screw System (September 17, 2015)

Other clearances for product code OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)