BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZVPLASTY

    Reg #: 3008583793 · FEI: 3008583793 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    119
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ZAVATION
    Registration Number
    3008583793
    FEI Number
    3008583793
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3670 Flowood Dr
    City
    Flowood
    State
    MS
    ZIP
    39232
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141419

    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
    Needle, Aspiration And Injection, Disposable GAA
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX

    Proprietary Names

    ZVPLASTY VCF-1020-2A 10 Gauge 20mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1007-8 8ga Cement Cannula VCF-DCDK-13 Double Cement Delivery Kit 13ga (8-Pack) VCF-1006-8 8ga Drill VCF-1315-DBK 13 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1023-8 8ga Diamond Trocar VCF-1023 10ga Diamond Trocar VCF-1006 10ga Drill VCF-1120-FLEX 20mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1310-1 13 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1310-SBK 13 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-1070-11 11ga co-ax cannulas VCF-1080-S4 Directional Cement Cannula 4-Pack VCF-20-CPL Curve Plus 20mm VCF-1110-FLEX 10mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1010-SBK 10 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1015-SBK 10 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1115-SBK 11 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1100-15 11 Gauge 15mm Kyphoplasty Balloon VCF-10-CPL Curve Plus 10mm VCF-1007 10ga Cement Cannula VCF-1010-DBK 10 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1020-DBK 10 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-DSSKbd-11 Single Bone Access kit for Injection 11ga VCF-1110-1 11 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1000-20, 10 Gauge 20mm Kyphoplasty Balloon VCF-1022 10ga Beveled Trocar VCF-1010-1 10 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-15-CPL Curve Plus 15mm VCF-1006-13 13ga Drill VCF-1006-11 11ga Drill VCF-1320-1 13 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1315-2 13 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-DSSKbd-13 Single Bone Access kit for Injection 13ga VCF-1015-1A 10 Gauge 15mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1023-11-S 11ga Diamond Stylet VCF-1100-20 11 Gauge 20mm Kyphoplasty Balloon VCF-1022-8 8ga Beveled Trocar VCF-1300-15 13 Gauge 15mm Kyphoplasty Balloon VCF-1007-11 11ga Cement Cannula VCF-1022-11 11ga Beveled Trocar VCF-1120-SBK 11 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1010-1A 10 Gauge 10mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1007-13 13ga Cement Cannula VCF-1010-2A 10 Gauge 10mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1310-2 13 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-DDSKbd-11 Double Bone Access Kit for Injection 11ga VCF-DSBAK-11 Direct Single Bone Access Kit 11ga VCF-1015-2A 10 Gauge 15mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1315-SBK 13 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1110-DBK 11 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-SCDK-11 Single Cement Delivery Kit 11ga (5-Pack) VCF-1023-S 10ga Diamond Stylet VCF-1010 10ga Biopsy Device VCF-1110-SBK 11 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1022-11-S 11ga Beveled Stylet VCF-1015-1 10 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-DDSKbd Double Bone Access Kit for Injection 10ga VCF-1310-DBK 13 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1120-1 11 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1115-DBK 11 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1320-DBK 13 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-DDBAK-13 Direct Double Bone Access Kit 13ga VCF-1110-2 11 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-1020-1 10 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1010-13 13ga Biopsy Device VCF-1020-SBK 10 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1300-10-L 13 Gauge 10mm Kyphoplasty Balloon (Long) VCF-1022-13-S 13ga Beveled Stylet VCF-1320-2 13 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1022-S 10ga Beveled Stylet VCF-1015-FLEX 10 Gauge 15mm Flex Direct Unilateral Kyphoplasty Kit VCF-1300-20-L 13 Gauge 20mm Kyphoplasty Balloon (Long) VCF-1010-FLEX 10 Gauge 10mm Flex Direct Unilateral Kyphoplasty Kit VCF-DSSKbd Single Bone Access kit for Injection 10ga VCF-1023-13-S 13ga Diamond Stylet VCF-FLCU-10 InterV CurvePlus Curved Cannula, 10G VCF-1115-FLEX 15mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1070 10ga co-ax cannulas VCF-1023-13 13ga Diamond Trocar VCF-1020-FLEX 10 Gauge 20mm Flex Direct Unilateral Kyphoplasty Kit VCF-DDBAK Direct Double Bone Access Kit 10ga 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-1300-10 13 Gauge 10mm Kyphoplasty Balloon VCF-KVTGUN-DS BPB Injector VCF-1015-DBK 10 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-DSBAK Direct Single Bone Access Kit 10ga VCF-1022-8-S 8ga Beveled Stylet VCF-1300-20 13 Gauge 20mm Kyphoplasty Balloon VCF-1120-2 11 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1020-1A 10 Gauge 20mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-DSBAK-13 Direct Single Bone Access Kit 13ga VCF-SCDK Single Cement Delivery Kit 10ga (5-Pack) VCF-1080-S Directional Cement Cannula VCF-1320-SBK 13 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-DCDK Double Cement Delivery Kit 10ga (8-Pack) VCF-DDBAK-11 Direct Double Bone Access Kit 11ga VCF-1120-DBK 11 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-1000-10 10 Gauge 10mm Kyphoplasty Balloon K05-02650 Digital Inflation Device VCF-1080-L Directional Cement Cannula (Long with Tuhoy Connection) VCF-1100-10, 11 Gauge 10mm Kyphoplasty Balloon VCF-1010-11 11ga Biopsy Device VCF-1115-1 11 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-1000-15, 10 Gauge 15mm Kyphoplasty Balloon VCF-1010-2 10 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-DCDK-11 Double Cement Delivery Kit 11ga (8-Pack) VCF-SCDK-13 Single Cement Delivery Kit 13ga (5-Pack) VCF-FLCU-11 InterV Flex Curved Cannula, 11G VCF-1023-8-S 8ga Diamond Stylet VCF-CCUR-11 InterV Flex Curved Curette, 11G VCF-1020-2 10 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1115-2 11 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1023-11 11ga Diamond Trocar

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198