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510(k) K221399

Device
ZIP™ MIS Interspinous Fusion System
Applicant
Aurora Spine, Inc.
510(k) number
K221399
Product code
PEK  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-08
Date received
2022-05-13
Regulation
888.3050
Classification name
Spinous Process Plate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Laszlo Garamszegi
Address
1930 Palomar Pt. Way Suite #103 Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC2025-12-01
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLC2024-01-18
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC2023-11-29
K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine2023-10-19
K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.2023-08-15
K223790Huvex Interspinous Fusion SystemDio Medical Corp.2023-03-09
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC2022-08-19
K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC2022-03-11
K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity, LLC2021-12-15
K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC2021-12-03
K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC2020-12-10
K201704CoFix SystemParadigm Spine GmbH2020-08-04
K182352SP-LINK™ SystemMedical Designs, LLC2018-11-21
K180817AERIAL™ Interspinous FixationGlobus Medical, Inc.2018-05-21
K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.2018-03-07

Legacy Summary#

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FDA Review#

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