Atlas FDA

PEK

48 FDA 510(k) clearances · Product code

99 daysmedian time to decision
306 days90th percentile
48clearances measured

FDA profile

Official device name
Spinous Process Plate
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Medical specialty
Orthopedic
Flags
Implant
FDA definition
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.
Adverse events (MAUDE)
2021: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Minuteman® G6 MIS Fusion Plate (K253250)Spinal Simplicity, LLC2025-12-01
Minuteman 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 (K234051)Spinal Simplicity, LLC2024-01-18
Minuteman 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 Plate (K233527)Spinal Simplicity, LLC2023-11-29
KeyLift™ Expandable Interlaminar Stabilization System (K232484)Amplio Spine, LLC2023-10-19
primaLOK™ SP Interspinous Fusion System (K231807)Wenzel Spine, Inc.2023-08-15
Huvex Interspinous Fusion System (K223790)Dio Medical Corp.2023-03-09
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023)Spinal Simplicity, LLC2022-08-19
ZIP™ MIS Interspinous Fusion System (K221399)Aurora Spine, Inc.2022-07-08
Minuteman G5 MIS Fusion Plate (K211880)Spinal Simplicity, LLC2022-03-11
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781)Spinal Simplicity, LLC2021-12-15
Inspan ScrewLES Fusion System (K213266)Lespine Innovations, LLC2021-12-03
Posterior Fusion Plate, HA Posterior Fusion Plate (K200066)Spinal Simplicity, LLC2020-12-10
CoFix System (K201704)Paradigm Spine GmbH2020-08-04
SP-LINK™ System (K182352)Medical Designs, LLC2018-11-21
AERIAL™ Interspinous Fixation (K180817)Globus Medical, Inc.2018-05-21
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (K180156)Globus Medical, Inc.2018-03-07
SeaSpine Spinous Process System (K173334)SeaSpine Orthopedics Corporation2018-02-22
Kalitec Direct InSePtion™ MIS Fixation System (K163471)Kalitec Direct, LLC2017-03-16
Huvex Interspinous Fixation System (K162849)Dio Medical Co., Ltd.2017-02-16
HA Minuteman G3-R MIS Fusion Plate (K163428)Spinal Simplicity2017-02-02
Z-Clamp ISP System (K161016)Zavation, LLC2016-10-19
coflex-IF (K153302)Paradigm Spine, LLC2016-09-08
Spinal Elements' Spinous Process Plate System (K160465)Spinal Elements, Inc.2016-07-28
Precision Spine Interspinous Plate System (K160568)Precision Spine, Inc.2016-05-04
Benefix Interspinous Fixation System (K143631)U&I Corporation2015-09-03
HA Minuteman G3 MIS Fusion Plate (K151741)Spinal Simplicity, LLC2015-08-20
Precision Spine Interspinous Plate System (K151863)Precision Spine, Inc.2015-08-07
Reliance Interspinous Plate System (K142217)Reliance Medical Systems, LLC2015-04-02
Affix IIS Spinous Process Plate System (K143388)Nu Vasive, Incorporated2015-03-05
SPINOUS PROCESS FUSION (SPF) PLATE (K140046)Spinal Simplicity, LLC2015-01-09
Interspinous Plate System (K142378)Precision Spine, Inc.2014-12-18
ZIP MIS INTERSPINOUS FUSION SYSTEM (K141317)Aurora Spine, Inc.2014-11-17
AILERON INTERSPINOUS FIXATION SYSTEM (K140236)Life Spine, Inc.2014-10-20
VIA SPINOUS PROCESS FIXATION SYSTEM (K142213)Spineology, Inc.2014-09-10
ROMEO 2 PAD POSTERIOR AXIAL DEVICE (K141508)Spineart2014-08-21
PFX SPINOUS PROCESS FIXATION SYSTEM (K132765)Innovasis, Inc.2014-07-14
ZIP MIS INTERSPINOUS FUSION SYSTEM (K140715)Aurora Spine, Inc.2014-04-17
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM (K133363)Ldr Spine USA, Inc.2014-03-07
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM (K133052)Nuvasive, Inc.2013-12-20
ZIP MIS INTERSPINOUS FUSION SYSTEM (K133091)Aurora Spine2013-11-27
SP-FIX SPINOUS PROCESS FIXATION PLATE (K132191)Globus Medical, Inc.2013-11-22
AFFIX II SPINOUS PROCESS PLATE SYSTEM (K132411)Nu Vasive, Incorporated2013-11-20
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) (K132968)Stryker Spine2013-11-18
SPECTRUM SPINE SPINOUS PROCESS DEVICE (K130066)Spectrum Spine IP Holdings, LLC2013-11-12
INTEGRA INTERSPINOUS PROCESS SYSTEM (K121924)Seaspine, Inc.2013-09-04
SUREFIX INTERSPINOUS FUSION SYSTEM (K124014)Jg Spine, LLC2013-08-09
AFFIX SPINOUS PROCESS PLATE SYSTEM (K131238)Nuvasive, Inc.2013-07-02
AXLE INTERSPINOUS FUSION SYSTEM (K130438)X-Spine Systems, Inc.2013-06-27

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Every clearance here is in the API, with alerts when new ones post.