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510(k) K172489

Reliance Cervical IBF System by Reliance Medical Systems, LLC — Product Code ODP

K172489 is an FDA 510(k) premarket notification submitted by Reliance Medical Systems, LLC for the device "Reliance Cervical IBF System". The FDA issued a decision of Substantially Equivalent on September 7, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Reliance Medical Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2017
Date Received
August 17, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Reliance Medical Systems, LLC

  • K202266 — Reliance Cervical IBF System (March 29, 2022)
  • K210874 — Reliance Spinal Screw System (May 13, 2021)
  • K183049 — Reliance Lumbar IBF System (February 15, 2019)
  • K181118 — Reliance Lumbar IBF System (January 9, 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)
  • 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 ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources