BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARCH - Quakertown

    Reg #: 2531477 · FEI: 3001642380 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    ARCH - Quakertown
    Registration Number
    2531477
    FEI Number
    3001642380
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    140 PENN AM DR.
    City
    QUAKERTOWN
    State
    PA
    ZIP
    18951
    Country
    US

    Owner / Operator

    Firm Name
    ARCH - Quakertown
    Operator Number
    9033309
    Address
    140 PENN AM DR., --
    City
    Quakertown
    State
    PA
    Postal Code
    18951
    Country
    US
    Correspondent
    Sydney Biehl

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Forceps HTD
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Plate, Fixation, Bone HRS
    Growing Rod System PGM
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Orthopedic Manual Surgical Instrument LXH
    Tap, Bone HWX
    Retractor GAD
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Wrist, Hemi-, Ulnar KXE
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Guide, Surgical, Instrument FZX
    Broach HTQ
    Screwdriver HXX
    Awl HWJ
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Osteotome, Manual GFI
    Spinal Vertebral Body Replacement Device MQP
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Screw, Fixation, Bone HWC
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Template HWT
    Rasp HTR
    Hammer, Surgical FZY
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM

    Proprietary Names

    WILSEY TOOL COMPANY ORTHO MAHWAH 14-1161X 14-1018X 14-1160X 14-1286X 14-2072X 14-1083 14-1390X 14-1374X 14-1375X 14-1379X 14-1062X 14-1368X 14-1082X 14-1386X 14-1185X 14-3076X 14-1380X 14-1441X 14-1285X 14-1019X 14-1186X 14-1442X 14-1438X 14-1399X 14-1369X 14-1184X 14-1373X 14-1481X TiLock2 Spinal System Anterior Cervical Plate System with Helios Technology Mountaineer Axial Connector Mountaineer Axial Connector 1883-11-104

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)