Product Code: PEK


Products Classified as PEK

4680Spinous Process PlateSpinal Interlaminal Fixation Orthosis.

Total Product Life Cycle (TPLC) Devices

4680Spinous Process PlateSpinal Interlaminal Fixation Orthosis.

FDA Consensus Standards

Spinous Process Plate [35574]21 CFR §888.3050 šŸ”Ž

Pre-market Notifications for PEK

K221399ZIPā„¢ MIS Interspinous Fusion SystemAurora Spine, Inc.
K213266Inspan ScrewLES Fusion SystemLESpine Innovations, LLC
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 LLC
K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity LLC
K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity LLC
K182352SP-LINKā„¢ SystemMedical Designs LLC
K180817AERIALā„¢ Interspinous FixationGlobus Medical Inc.
K180156SP-FixĀ® Spinous Process Fixation Plate, RELIEVEĀ® Laminoplasty Fixation SystemGlobus Medical Inc.
K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation
K163471Kalitec Direct InSePtionā„¢ MIS Fixation SystemKALITEC DIRECT, LLC
K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity
K162849Huvex Interspinous Fixation SystemDIO MEDICAL CO., LTD.
K161016Z-Clamp ISP SystemZavation, LLC
K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.
K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements Inc.

Global Unique Device Identification Database

00190837000592Spinous Process Plate
00190837000585Spinous Process Plate
00190837000578Spinous Process Plate
00190837000561Spinous Process Plate
00190837000554Spinous Process Plate
00190837000547Spinous Process Plate
00190837000530Spinous Process Plate
00190837000523Spinous Process Plate
00190837000516Spinous Process Plate
00190837000509Spinous Process Plate
00190837000493Spinous Process Plate
00190837000486Spinous Process Plate
00190837000479Spinous Process Plate
00190837000462Spinous Process Plate
00190837000455Spinous Process Plate

Maude Adverse Events

INTERBRIDGE LOCKING PLATE SLDR MEDICAL2019-11-15
AFFIX PLATENUVASIVE2019-08-14
AFFIXNUVASIVE2019-08-14
INTERBRIDGE IMPLANT HOLDERLDR M?DICAL2019-05-03
AXLE INTERSPINOUS FUSION SYSTEMX-SPINE SYSTEMS, INC.2018-09-14
AXLE INTERSPINOUS FUSION SYSTEMX-SPINE SYSTEMS, INC.2018-09-04
PEEK SPACER INTRODUCER HANDLEAURORA SPINE, INC.2015-01-29
ZIP INTERSPINOUS FUSION SYSTEMAURORA SPINE, INC.2015-01-29
ZIP MIS INTERSPINOUS FUSION SYSTEMAURORA SPINE2015-01-16
ZIP INTERSPINOUS FUSION SYSTEMAURORA SPINE, INC2015-01-08
UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MMSTRYKER SPINE-SWITZERLAND2014-01-13
UNIVISE SPINOUS PROCESS FIXATION PLATE, 35MMSTRYKER SPINE-SWITZERLAND2014-01-08
NUVASIVE SPINOUS PROCESS PLATE SYSTEMNUVASIVE, INC.2011-11-14
NUVASIVE SPINOUS PROCESS PLATE SYSTEMNUVASIVE, INC.2011-11-14
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