BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHALBY ADVANCED TECHNOLOGIES, INC.

    Reg #: 3020155054 · FEI: 3020155054 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    45

    Registration Details

    Registration Name
    SHALBY ADVANCED TECHNOLOGIES, INC.
    Registration Number
    3020155054
    FEI Number
    3020155054
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1115 Windfield Way
    City
    El Dorado Hills
    State
    CA
    ZIP
    95762
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100933

    Owner / Operator

    Firm Name
    Shalby Advanced Technologies, Inc.
    Operator Number
    10082275
    Address
    1115 Windfield Way
    City
    El Dorado Hills
    State
    CA
    Postal Code
    95762
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Chisel, Surgical, Manual FZO
    Reamer HTO
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Extractor HWB
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Gauge, Depth HTJ
    Guide, Surgical, Instrument FZX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    File HTP
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Driver, Surgical, Pin GFC
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Forceps HTD
    Hammer, Surgical FZY
    Broach HTQ
    Orthopedic Manual Surgical Instrument LXH
    Wrench HXC
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Rod, Fixation, Intramedullary And Accessories HSB
    Rasp HTR
    Awl HWJ
    Punch, Surgical LRY
    Retractor GAD
    Guide, Drill, Ligament LXI
    Driver, Prosthesis HWR
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Tray, Surgical, Instrument FSM
    Caliper KTZ
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Template HWT
    Apparatus, Traction, Non-Powered HST
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Osteotome, Manual GFI
    Screwdriver HXX
    Bit, Drill HTW
    Impactor HWA

    Proprietary Names

    Bone Chisel Bone File Ambition Knee Pin Driver Screw Forceps Slap Hammer DC-POWERED ORTHOPEDIC INSTRUMENT ACCESSORY/ATTACHMENT Wrench Tahoe Uni Knee System Punch Retractor Powered Drill Bit Powered Reamer Driver, Prosthesis Optimotion Implants Porous Metal-Backed Patella Tahoe Unicondylar Knee System with TiNbN Overcoat Consensus Knee System VitalitE Tibial Insert and Patellar Components Duraniom

    Establishment Types

    Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)