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510(k) K221023

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 by Spinal Simplicity, LLC — Product Code PEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2022
Date Received
April 6, 2022
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 Spinal Simplicity, LLC

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  • K250001 — Patriot SI Implant System (June 3, 2025)
  • K240592 — Wolff's Law Anterior Cervical Plate System (May 24, 2024)
  • K232259 — Patriot-SI Posterior Implant System (April 19, 2024)
  • K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior (January 18, 2024)
  • K231923 — Liberty SI Lateral Implant System (December 5, 2023)
  • K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterio (November 29, 2023)
  • K221307 — Edge Upper Cervical System (July 10, 2023)
  • K211880 — Minuteman G5 MIS Fusion Plate (March 11, 2022)
  • K212781 — Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, (December 15, 2021)

Other clearances for product code PEK

  • K253250 — Minuteman® G6 MIS Fusion Plate (December 1, 2025)
  • K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior (January 18, 2024)
  • K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterio (November 29, 2023)
  • K232484 — KeyLift™ Expandable Interlaminar Stabilization System (October 19, 2023)
  • K231807 — primaLOK™ SP Interspinous Fusion System (August 15, 2023)
  • K223790 — Huvex Interspinous Fusion System (March 9, 2023)
  • K221399 — ZIP™ MIS Interspinous Fusion System (July 8, 2022)
  • K211880 — Minuteman G5 MIS Fusion Plate (March 11, 2022)
  • K212781 — Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, (December 15, 2021)
  • K213266 — Inspan ScrewLES Fusion System (December 3, 2021)