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510(k) K123521

RELIANCE SPINAL SCREW SYSTEM by Reliance Medical Systems, LLC — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
November 15, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle 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)
  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K160463 — Reliance Lumbar IBF System (May 20, 2016)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)