BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSTEOMED

    Reg #: 2027754 · FEI: 2027754 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    6
    Establishment Types
    7
    Classifications
    59

    Registration Details

    Registration Name
    OSTEOMED
    Registration Number
    2027754
    FEI Number
    2027754
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3885 Arapaho Rd
    City
    ADDISON
    State
    TX
    ZIP
    75001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131445

    Owner / Operator

    Firm Name
    OSTEOMED
    Operator Number
    9000613
    Address
    3885 Arapaho Rd., --
    City
    Addison
    State
    TX
    Postal Code
    75001
    Country
    US
    Correspondent
    Kathryn Jayne

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Clamp HXD
    Clamp, Surgical, General & Plastic Surgery GDJ
    Goniometer, Nonpowered KQW
    Holder, Needle; Orthopedic HXK
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Prosthesis, Toe, Constrained, Polymer KWH
    System, Image Processing, Radiological LLZ
    Impactor HWA
    Screw, Fixation, Bone HWC
    Screwdriver HXX
    Punch, Surgical LRY
    External Mandibular Fixator And/Or Distractor MQN
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Plate, Bone JEY
    Reamer HTO
    Washer, Bolt Nut HTN
    Rasp, Surgical, General & Plastic Surgery GAC
    Screw, Fixation, Intraosseous DZL
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Surgical, General & Plastic Surgery GFF
    Orthopedic Manual Surgical Instrument LXH
    Staple, Fixation, Bone JDR
    Handpiece, Rotary Bone Cutting KMW
    Guide, Surgical, Instrument FZX
    Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained LZJ
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Hammer, Surgical FZY
    Driver, Wire, And Bone Drill, Manual DZJ
    Hook, Bone KIK
    Bender HXW
    Plate, Cranioplasty, Preformed, Alterable GWO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Instrument, Compression HWN
    File HTP
    Curette HTF
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Cranial Distraction System PBJ
    Rongeur, Manual HAE
    Template HWT
    Filler, Bone Void, Calcium Compound MQV
    Prosthesis, Condyle, Mandibular, Temporary NEI
    Gauge, Depth HTJ
    Cover, Burr Hole GXR
    Cutter, Wire HXZ
    Countersink HWW
    Instrument, Manual, Surgical, General Use MDM
    Broach HTQ
    Implant, Endosseous, Root-Form DZE
    Bur, Dental EJL
    Tap, Bone HWX
    Syringe, Piston FMF
    Instrument, Surgical, Non-Powered HAO
    Forceps HTD
    Handpiece, Air-Powered, Dental EFB
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Elevator HTE
    Bit, Drill HTW
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Goniometer Sharp Hook Compressor Instrument Ring Curette Cup Curette Dental Burs

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Sterilize Medical Device for Another Party (Contract Sterilizer)