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510(k) K183049

Reliance Lumbar IBF System by Reliance Medical Systems, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2019
Date Received
November 2, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize 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)
  • 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)
  • 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)

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