BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Arthocare8208 (CR2) - RAPTORMITE 3.7 AB W/NDL 20 ULTRABRAID

    Reg #: 3010273872 · FEI: 3010273872 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Synergy Health AST, SRL
    Registration Number
    3010273872
    FEI Number
    3010273872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B13.1 Street 4, Avenue 1, Coyol Free Zone
    City
    Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K151105

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    Synergy Health AST, LLC
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Staple, Fixation, Bone JDR
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Screw, Fixation, Bone HWC

    Proprietary Names

    Arthocare8208 (CR2) - RAPTORMITE 3.7 AB W/NDL 20 ULTRABRAID Arthocare8208 (CR2) - TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK Arthocare8208 (CR2) - ULTRA FAST-FIX AB ASSEMBLY – STRAIGHT Arthocare8208 (CR2) - TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL Arthocare8208 (CR2) - OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE Arthocare8208 (CR2) - TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Arthocare8208 (CR2) - OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK Arthocare8208 (CR2) - TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK Arthocare8208 (CR2) - ULTRA FAST-FIX AB ASSEMBLY – REV CURVE Arthocare8208 (CR2) - TWINFIX ULTRA PLLA/HA 6.5 W/3 UB Arthocare8208 (CR2) - TF ULTRA 2 UB AND NDLS 5.5MM PLLA/HA Arthocare8208 (CR2) - OSTEORAPTOR 2.3 W. UB COBRAID BLUE Arthocare8208 (CR2) - TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL Arthocare8208 (CR2) - OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK Arthocare8208 (CR2) - OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK Arthocare8208 (CR2) - ULTRA FAST-FIX AB ASSEMBLY – CURVED Arthocare8208 (CR2) - OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE Arthocare8208 (CR2) - TF ULTRA 2 UB AND NDLS 6.5MM PLLA/HA Arthocare8208 (CR2) - OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE Arthocare8208 (CR2) - TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK) Arthocare8208 (CR2) - TF ULTRA 2 UB AND NDLS 4.5MM PLLA/HA

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)