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510(k) K210874

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

K210874 is an FDA 510(k) premarket notification submitted by Reliance Medical Systems, LLC for the device "Reliance Spinal Screw System". The FDA issued a decision of Substantially Equivalent on May 13, 2021. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Reliance Medical Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2021
Date Received
March 24, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Reliance Medical Systems, LLC

  • K202266 — Reliance Cervical IBF System (March 29, 2022)
  • 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)
  • K152131 — Reliance Spinal Screw System (September 17, 2015)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources