ClearanceBrief
Panels › Orthopedic › Product code PEK · Class 2

Spinous Process Plate

Regulation 888.3050

2510(k)s in 12 months (49 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in PEK

Company510(k)sRecalls
Spinal Simplicity110
Aurora Spine40
Globus Medical, Inc.30
Precision Spine, Inc.30
Dio Medical Co., Ltd.20
Nu Vasive, Incorporated20
Nuvasive, Inc.20
Paradigm Spine GmbH20
Amplio Spine, LLC10
Innovasis, Inc.10
Decided510(k)Device and applicantCode
Oct 2, 2026K261607Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion
Spinal Simplicity, LLC
PEK
Dec 1, 2025K253250Minuteman® G6 MIS Fusion Plate
Spinal Simplicity, LLC
PEK
Jan 18, 2024K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fu
Spinal Simplicity, LLC
PEK
Nov 29, 2023K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS F
Spinal Simplicity, LLC
PEK
Oct 19, 2023K232484KeyLift™ Expandable Interlaminar Stabilization System
Amplio Spine, LLC
PEK
Aug 15, 2023K231807primaLOK™ SP Interspinous Fusion System
Wenzel Spine, Inc.
PEK
Mar 9, 2023K223790Huvex Interspinous Fusion System
Dio Medical Corp.
PEK
Aug 19, 2022K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minute
Spinal Simplicity, LLC
PEK
Jul 8, 2022K221399ZIP™ MIS Interspinous Fusion System
Aurora Spine, Inc.
PEK
Mar 11, 2022K211880Minuteman G5 MIS Fusion Plate
Spinal Simplicity, LLC
PEK
Dec 15, 2021K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Mi
Spinal Simplicity, LLC
PEK
Dec 3, 2021K213266Inspan ScrewLES Fusion System
Lespine Innovations, LLC
PEK
Dec 10, 2020K200066Posterior Fusion Plate, HA Posterior Fusion Plate
Spinal Simplicity, LLC
PEK
Aug 4, 2020K201704CoFix System
Paradigm Spine GmbH
PEK
Nov 21, 2018K182352SP-LINK™ System
Medical Designs, LLC
PEK
May 21, 2018K180817AERIAL™ Interspinous Fixation
Globus Medical, Inc.
PEK
Mar 7, 2018K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Globus Medical, Inc.
PEK
Feb 22, 2018K173334SeaSpine Spinous Process System
SeaSpine Orthopedics Corporation
PEK
Mar 16, 2017K163471Kalitec Direct InSePtion™ MIS Fixation System
Kalitec Direct, LLC
PEK
Feb 16, 2017K162849Huvex Interspinous Fixation System
Dio Medical Co., Ltd., KR
PEK
Feb 2, 2017K163428HA Minuteman G3-R MIS Fusion Plate
Spinal Simplicity
PEK
Oct 19, 2016K161016Z-Clamp ISP System
Zavation, LLC
PEK
Sep 8, 2016K153302coflex-IF
Paradigm Spine, LLC
PEK
Jul 28, 2016K160465Spinal Elements' Spinous Process Plate System
Spinal Elements, Inc.
PEK
May 4, 2016K160568Precision Spine Interspinous Plate System
Precision Spine, Inc.
PEK
Sep 3, 2015K143631Benefix Interspinous Fixation System
U&I Corporation, KR
PEK
Aug 20, 2015K151741HA Minuteman G3 MIS Fusion Plate
Spinal Simplicity, LLC
PEK
Aug 7, 2015K151863Precision Spine Interspinous Plate System
Precision Spine, Inc.
PEK
Apr 2, 2015K142217Reliance Interspinous Plate System
Reliance Medical Systems, LLC
PEK
Mar 5, 2015K143388Affix IIS Spinous Process Plate System
Nu Vasive, Incorporated
PEK
Jan 9, 2015K140046SPINOUS PROCESS FUSION (SPF) PLATE
Spinal Simplicity, LLC
PEK
Dec 18, 2014K142378Interspinous Plate System
Precision Spine, Inc.
PEK
Nov 17, 2014K141317ZIP MIS INTERSPINOUS FUSION SYSTEM
Aurora Spine, Inc.
PEK
Oct 20, 2014K140236AILERON INTERSPINOUS FIXATION SYSTEM
Life Spine, Inc.
PEK
Sep 10, 2014K142213VIA SPINOUS PROCESS FIXATION SYSTEM
Spineology, Inc.
PEK
Aug 21, 2014K141508ROMEO 2 PAD POSTERIOR AXIAL DEVICE
Spineart, CH
PEK
Jul 14, 2014K132765PFX SPINOUS PROCESS FIXATION SYSTEM
Innovasis, Inc.
PEK
Apr 17, 2014K140715ZIP MIS INTERSPINOUS FUSION SYSTEM
Aurora Spine, Inc.
PEK
Mar 7, 2014K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
Ldr Spine USA, Inc.
PEK
Dec 20, 2013K133052AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
Nuvasive, Inc.
PEK
Nov 27, 2013K133091ZIP MIS INTERSPINOUS FUSION SYSTEM
Aurora Spine
PEK
Nov 22, 2013K132191SP-FIX SPINOUS PROCESS FIXATION PLATE
Globus Medical, Inc.
PEK
Nov 20, 2013K132411AFFIX II SPINOUS PROCESS PLATE SYSTEM
Nu Vasive, Incorporated
PEK
Nov 18, 2013K132968UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
Stryker Spine
PEK
Nov 12, 2013K130066SPECTRUM SPINE SPINOUS PROCESS DEVICE
Spectrum Spine IP Holdings, LLC
PEK
Sep 4, 2013K121924INTEGRA INTERSPINOUS PROCESS SYSTEM
Seaspine, Inc.
PEK
Aug 9, 2013K124014SUREFIX INTERSPINOUS FUSION SYSTEM
Jg Spine, LLC
PEK
Jul 2, 2013K131238AFFIX SPINOUS PROCESS PLATE SYSTEM
Nuvasive, Inc.
PEK
Jun 27, 2013K130438AXLE INTERSPINOUS FUSION SYSTEM
X-Spine Systems, Inc.
PEK

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