Home / 510(k) Clearances / K140715

510(k) K140715

ZIP MIS INTERSPINOUS FUSION SYSTEM by Aurora Spine, Inc. — Product Code PEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2014
Date Received
March 21, 2014
Clearance Type
Special
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 Aurora Spine, Inc.

  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K221047 — SILO TFX MIS Sacroiliac Joint Fixation System (October 3, 2022)
  • K221399 — ZIP™ MIS Interspinous Fusion System (July 8, 2022)
  • K220610 — SOLO-L (May 27, 2022)
  • K210521 — DEXA-C Cervical Interbody System (August 2, 2021)
  • K210325 — APOLLO Anterior Cervical Plate (ACP) System (March 23, 2021)
  • K141317 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 17, 2014)
  • K133967 — INTERBODY CAGE SYSTEM (January 31, 2014)
  • K133091 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 27, 2013)

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)
  • K221023 — Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA (August 19, 2022)
  • 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)