BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISOTIS ORTHOBIOLOGICS, INC

    Reg #: 2090010 · FEI: 3001503333 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    57
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    ISOTIS ORTHOBIOLOGICS, INC
    Registration Number
    2090010
    FEI Number
    3001503333
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Goodyear
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050642

    Owner / Operator

    Firm Name
    SeaSpine Orthopedics Corporation
    Operator Number
    10049589
    Address
    5770 Armada Dr
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Bone Grafting Material, Human Source NUN
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    OrthoBlast II Paste OrthoBlast II Putty Trel-XC Paste Trel-XC Putty OsteoSparx C Paste OsteoSparx C Putty AlloSync CB DBM AlloSync CB DBM Paste AlloSync CB DBM Putty OrthoBlast II DBM Putty OrthoBlast II DBM Paste DynaBlast Putty DynaBlast Paste OsteoSurge 300 Accell Evo3 (formerly (A2) OsteoSurge 100 Accell Connexus Accell TBM Cove Putty OsteoCove Putty OsteoBallast Ballast OsteoBallast MT Ballast MT OsteoSparx Gel OsteoSparx Putty DynaGraft II Putty DynaGraft II Gel Trel-X Putty Trel-X Gel AlloSync DBM AlloSync DBM Gel AlloSync DBM Putty Cove Strip OsteoCove Strip OsteoSurge 300C Accell Evo3C DynaGraft D Gel DynaGraft D Putty IsoTis Mozaik Strip OsteoStrux Strip Orthofix Collage Strip Arthrex BoneSync Strip Accell Evo3 (formerly A2) OsteoStrux Putty IsoTis Mozaik Putty Orthofix Collage Osteoconductive Scaffold Putty (Orthofix Collage Putty) Orthofix Collage Putty Arthrex BoneSync Putty Torrent OsteoTorrent Torrent C OsteoTorrent C Current, OsteoCurrent Accell Connexus Keystone Dental IsoTis® Facet Fusion Instruments FLASH™ Facet Fusion Instruments

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility