BEUDAMED
    Product Code: PEK FDA class 2 21 CFR 888.3050

    Spinous Process Plate

    Orthopedic

    The Spinous Process Plate is an orthopedic implant designed as a posterior, non-pedicle supplemental fixation device intended for single-level use in the non-cervical spine (T1-S1), typically used to provide additional stabilization in conjunction with anterior lumbar interbody fusion procedures. It falls under the Orthopedic medical specialty and is classified as a Class 2 device under regulation 888.3050, requiring 510(k) premarket notification. As an implanted device, it is subject to general controls and special controls; it is not considered life-sustaining.

    View on FDA
    510(k)s
    48
    FEI Numbers
    75
    Registration Numbers
    75
    Unique Applicants
    32
    Years Active
    12

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    Basic Information

    Product Code
    PEK
    Device Class
    FDA class 2
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 48 510(k) clearances via K numbers.

    K Number Device Name
    K253250 Minuteman® G6 MIS Fusion Plate
    K234051 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
    K233527 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
    K232484 KeyLift™ Expandable Interlaminar Stabilization System
    K231807 primaLOK™ SP Interspinous Fusion System
    K223790 Huvex Interspinous Fusion System
    K221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
    K221399 ZIP™ MIS Interspinous Fusion System
    K211880 Minuteman G5 MIS Fusion Plate
    K212781 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
    K213266 Inspan ScrewLES Fusion System
    K200066 Posterior Fusion Plate, HA Posterior Fusion Plate
    K201704 CoFix System
    K182352 SP-LINK™ System
    K180817 AERIAL™ Interspinous Fixation
    K180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
    K173334 SeaSpine Spinous Process System
    K163471 Kalitec Direct InSePtion™ MIS Fixation System
    K162849 Huvex Interspinous Fixation System
    K163428 HA Minuteman G3-R MIS Fusion Plate
    K161016 Z-Clamp ISP System
    K153302 coflex-IF
    K160465 Spinal Elements' Spinous Process Plate System
    K160568 Precision Spine Interspinous Plate System
    K143631 Benefix Interspinous Fixation System
    K151741 HA Minuteman G3 MIS Fusion Plate
    K151863 Precision Spine Interspinous Plate System
    K142217 Reliance Interspinous Plate System
    K143388 Affix IIS Spinous Process Plate System
    K140046 SPINOUS PROCESS FUSION (SPF) PLATE
    K142378 Interspinous Plate System
    K141317 ZIP MIS INTERSPINOUS FUSION SYSTEM
    K140236 AILERON INTERSPINOUS FIXATION SYSTEM
    K142213 VIA SPINOUS PROCESS FIXATION SYSTEM
    K141508 ROMEO 2 PAD POSTERIOR AXIAL DEVICE
    K132765 PFX SPINOUS PROCESS FIXATION SYSTEM
    K140715 ZIP MIS INTERSPINOUS FUSION SYSTEM
    K133363 INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
    K133052 AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
    K133091 ZIP MIS INTERSPINOUS FUSION SYSTEM
    K132191 SP-FIX SPINOUS PROCESS FIXATION PLATE
    K132411 AFFIX II SPINOUS PROCESS PLATE SYSTEM
    K132968 UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
    K130066 SPECTRUM SPINE SPINOUS PROCESS DEVICE
    K121924 INTEGRA INTERSPINOUS PROCESS SYSTEM
    K124014 SUREFIX INTERSPINOUS FUSION SYSTEM
    K131238 AFFIX SPINOUS PROCESS PLATE SYSTEM
    K130438 AXLE INTERSPINOUS FUSION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 75 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 75 registration numbers. Click on an entry to view related FDA registrations.