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510(k) K162066

Reliance Spinal Screw System by Reliance Medical Systems, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2016
Date Received
July 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Reliance Medical Systems, LLC

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  • 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)
  • K160463 — Reliance Lumbar IBF System (May 20, 2016)
  • K152131 — Reliance Spinal Screw System (September 17, 2015)

Other clearances for product code MNH

  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)
  • K151116 — CapLOX II/TowerLOX Pedicle Screw System (June 26, 2015)