BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZAVATION

    Reg #: 3008583793 · FEI: 3008583793 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    214
    Establishment Types
    4
    Classifications
    47

    Registration Details

    Registration Name
    ZAVATION
    Registration Number
    3008583793
    FEI Number
    3008583793
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3670 Flowood Dr
    City
    Flowood
    State
    MS
    ZIP
    39232
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180556

    Owner / Operator

    Firm Name
    Zavation Medical Products LLC
    Operator Number
    10055475
    Address
    3670 Flowood Dr
    City
    Flowood
    State
    MS
    Postal Code
    39232
    Country
    US
    Correspondent
    Elke Carter

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Bender HXW
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Rasp, Surgical, General & Plastic Surgery GAC
    Wrench HXC
    Posterior Cervical Screw System NKG
    Screw, Fixation, Bone HWC
    Sacroiliac Joint Fixation OUR
    Mixer, Cement, For Clinical Use JDZ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Tap, Bone HWX
    Instrument, Bending Or Contouring HXP
    Filler, Bone Void, Calcium Compound MQV
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Cutter, Wire HXZ
    Rongeur HTX
    Broach HTQ
    Spinous Process Plate PEK
    Needle, Aspiration And Injection, Disposable GAA
    Accessories, Fixation, Spinal Intervertebral Body LYQ
    Template HWT
    System, Facet Screw Spinal Device MRW
    Reamer HTO
    Awl HWJ
    Passer, Wire, Orthopedic HXI
    Tamp HXG
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Caliper KTZ
    Gauge, Depth HTJ
    Orthopedic Manual Surgical Instrument LXH
    Osteotome HWM
    Screwdriver HXX
    Instrument, Compression HWN
    Bit, Drill HTW
    Probe HXB
    Curette HTF

    Proprietary Names

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR InterV Bone Access Cannula; InterV Bone Access Needle; Blue Diamond Digital Inflation InterV Curette; InterV Direct Access Needle Vertebrex Bone Access Needle; Vertebrex Curette; InterV Drill; InterV Flex Needle; Vertebrex Kirschner Wire; ZV Plasty Direct Access Needle InterV Kirschner Wire; Vertebrex Bone Access Cannula; Vertebrex Direct Access Needle; Vertebrex Drill; Vertebrex Flex Needle Atrion QL2530 Inflation Device Bender APPLIANCE, FIXATION, SPINAL INTERLAMINAL ORTHOPEDIC STEREOTAXIC INSTRUMENT Zavation IBF EZ Plate InterV Kyphoplasty Catheter (Micro)/Kit; InterV Kyphoplasty Catheter (Mini)/Kit; InterV Kyphoplasty Catheter/Kit; Vertebrex Kyphoplasty Catheter (Flex)/Kit; Vertebrex Kyphoplasty Catheter (Micro)/Kit; Vertebrex Kyphoplasty Catheter (Mini)/Kit; 11G Renova Spine Balloon Catheter/Kit; InterV Kyphoplasty Catheter (Flex)/Kit; ZV Plasty Kyphoplasty Catheter (Mini) Vertebrex Kyphoplasty Catheter/Kit; ZV Plasty Kyphoplasty Catheter Ti 3Z Interbody System Zavation Ti3Z Cervical System SPINAL INTERVERTEBRAL BODY TIGER SPINE SYSTEM RASP, SURGICAL, GENERAL & PLASTIC SURGERY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Wrench SI Screw System ZMI-90 Mixing and Injection System Labyrinth Zavation Cervical Plate System NanoPrime System Tap, Bone Z-Span Plate System INSTRUMENT, BENDING OR CONTOURING InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20 mm) InterV Kyphoplasty Catheter (Balloon lengthL 10;15 and 20 mm) UNIFUZE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Zavation Connector System Normandy VBR System Zavation Z-Link Lumbar CoreLink® M3™ Stand-Alone Anterior Lumbar System Unifuze-C Bone Strip ZAVATION CERVICAL PLATE SYSTEM Wire Cutter ZV Graft RONGEUR Broach Z-Clamp ISP System F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System Tiger 2 System Zavation VariSync™ System Z-LINK CERVICAL Spinal Interlaminal APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) ZVPLASTY VCF-1020-DBK 10 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-DDBAK-11 Direct Double Bone Access Kit 11ga VCF-1110-SBK 11 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-DSSKbd-13 Single Bone Access kit for Injection 13ga VCF-1010-1 10 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1023-11-S 11ga Diamond Stylet VCF-1100-10, 11 Gauge 10mm Kyphoplasty Balloon VCF-1010-11 11ga Biopsy Device VCF-1023 10ga Diamond Trocar VCF-1010-2 10 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-FLCU-11 InterV Flex Curved Cannula, 11G VCF-1023-8-S 8ga Diamond Stylet VCF-1120-FLEX 20mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1010-13 13ga Biopsy Device VCF-1020-SBK 10 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1000-10 10 Gauge 10mm Kyphoplasty Balloon VCF-1006-11 11ga Drill VCF-1020-FLEX 10 Gauge 20mm Flex Direct Unilateral Kyphoplasty Kit VCF-1080-L Directional Cement Cannula (Long with Tuhoy Connection) VCF-DCDK-13 Double Cement Delivery Kit 13ga (8-Pack) VCF-15-CPL Curve Plus 15mm VCF-1315-DBK 13 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1110-FLEX 10mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1015-SBK 10 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1115-SBK 11 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1115-DBK 11 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1110-2 11 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-1310-1 13 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1310-SBK 13 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1020-1 10 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1010-DBK 10 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-DCDK Double Cement Delivery Kit 10ga (8-Pack) VCF-1320-2 13 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1110-1 11 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1120-DBK 11 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-1120-2 11 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1080-S Directional Cement Cannula VCF-DSBAK Direct Single Bone Access Kit 10ga VCF-10-CPL Curve Plus 10mm VCF-1000-20, 10 Gauge 20mm Kyphoplasty Balloon VCF-1022 10ga Beveled Trocar VCF-1006-8 8ga Drill VCF-1300-20 13 Gauge 20mm Kyphoplasty Balloon VCF-1023-13-S 13ga Diamond Stylet VCF-1015-FLEX 10 Gauge 15mm Flex Direct Unilateral Kyphoplasty Kit VCF-DSBAK-13 Direct Single Bone Access Kit 13ga VCF-SCDK Single Cement Delivery Kit 10ga (5-Pack) VCF-1300-15 13 Gauge 15mm Kyphoplasty Balloon VCF-1320-DBK 13 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-1022-8 8ga Beveled Trocar VCF-1022-11 11ga Beveled Trocar VCF-1120-SBK 11 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1070-11 11ga co-ax cannulas VCF-1015-1A 10 Gauge 15mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1015-1 10 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-1023-8 8ga Diamond Trocar VCF-1115-1 11 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-1320-1 13 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1006 10ga Drill VCF-1000-15, 10 Gauge 15mm Kyphoplasty Balloon VCF-1080-S4 Directional Cement Cannula 4-Pack VCF-20-CPL Curve Plus 20mm VCF-SCDK-13 Single Cement Delivery Kit 13ga (5-Pack) VCF-DDSKbd Double Bone Access Kit for Injection 10ga VCF-1022-S 10ga Beveled Stylet VCF-1120-1 11 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1100-20 11 Gauge 20mm Kyphoplasty Balloon VCF-1007-11 11ga Cement Cannula VCF-1010-1A 10 Gauge 10mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1100-15 11 Gauge 15mm Kyphoplasty Balloon VCF-1022-8-S 8ga Beveled Stylet VCF-DDBAK-13 Direct Double Bone Access Kit 13ga VCF-1007 10ga Cement Cannula VCF-DSSKbd Single Bone Access kit for Injection 10ga VCF-FLCU-10 InterV CurvePlus Curved Cannula, 10G VCF-1300-10-L 13 Gauge 10mm Kyphoplasty Balloon (Long) VCF-1022-13-S 13ga Beveled Stylet VCF-1310-DBK 13 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1300-10 13 Gauge 10mm Kyphoplasty Balloon VCF-1010-2A 10 Gauge 10mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1310-2 13 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-SCDK-11 Single Cement Delivery Kit 11ga (5-Pack) VCF-1300-20-L 13 Gauge 20mm Kyphoplasty Balloon (Long) VCF-DDSKbd-11 Double Bone Access Kit for Injection 11ga VCF-1115-2 11 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1020-2A 10 Gauge 20mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1007-8 8ga Cement Cannula VCF-1010-SBK 10 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1300-15-L 13 Gauge 15mm Kyphoplasty Balloon (Long) VCF-1015-2 10 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1022-11-S 11ga Beveled Stylet VCF-1020-1A 10 Gauge 20mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1010-FLEX 10 Gauge 10mm Flex Direct Unilateral Kyphoplasty Kit VCF-DSBAK-11 Direct Single Bone Access Kit 11ga VCF-1320-SBK 13 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1006-13 13ga Drill K05-02650 Digital Inflation Device VCF-1315-2 13 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1022-13 13ga Beveled Trocar VCF-1315-1 13 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-DDSKbd-13 Double Bone Access Kit for Injection 13ga VCF-KVTGUN-DS BPB Injector VCF-1015-DBK 10 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1007-13 13ga Cement Cannula VCF-CCUR-11 InterV Flex Curved Curette, 11G VCF-1020-2 10 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1015-2A 10 Gauge 15mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1023-11 11ga Diamond Trocar VCF-1115-FLEX 15mm Flex Direct Unilateral Kyphoplasty Balloon VCF-DCDK-11 Double Cement Delivery Kit 11ga (8-Pack) VCF-1070 10ga co-ax cannulas VCF-DSSKbd-11 Single Bone Access kit for Injection 11ga VCF-1023-13 13ga Diamond Trocar VCF-DDBAK Direct Double Bone Access Kit 10ga VCF-1315-SBK 13 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1110-DBK 11 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1023-S 10ga Diamond Stylet VCF-1010 10ga Biopsy Device ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY Varisync® ALIF System Template Uni-FuZe-P Bone Putty Zavation Fenestrated Facet Screw System Zavation IBF System SPONDYLOLISTHESIS SPINAL FIXATION Zavation eZspand Interbody System Sacroiliac Joint Fixation Reamer Awl Zavation MILC System Zavation Spinal System PASSER, WIRE, ORTHOPEDIC Unifuze Putty SCREW, FIXATION, BONE CoreLink Navigation Instruments ZAVATION IBF SYSTEMS Normandy Cervical VBR System Tamp Maxinject Cement Delivery System (Gun); Mininject Cement Delivery System (Syringe) S5 Mixing & Injection System; Vertebrex Cement Delivery Cannula and Syringe; Vertebrex Flex Needle InterV Cement Delivery Cannula and Syringe; InterV Flex Needle; Z-LINKPC System ZAVATION SPINAL SYSTEM ZAVATION IBF SYSTEM Caliper Gauge, Depth Zavation Spinal System- Cortical Screw SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Zavation SIBI Instrument System OSTEOTOME Screwdriver INSTRUMENT, COMPRESSION Bit, Drill Zavation Posterior LEIF PROBE CURETTE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility