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510(k) K142217

Reliance Interspinous Plate System by Reliance Medical Systems, LLC — Product Code PEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2015
Date Received
August 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinous Process Plate
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.

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)
  • K172489 — Reliance Cervical IBF System (September 7, 2017)
  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K160463 — Reliance Lumbar IBF System (May 20, 2016)

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