BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CEP BIO-COAT, LLC

    Reg #: 3011277306 · FEI: 3011277306 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    CEP BIO-COAT, LLC
    Registration Number
    3011277306
    FEI Number
    3011277306
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23149 Commerce Drive
    City
    Farmington Hills
    State
    MI
    ZIP
    48335
    Country
    US

    Owner / Operator

    Firm Name
    CEP Bio-Coat, LLC D/B/A Orchid Orthopedic Solutions, LLC
    Operator Number
    10042681
    Address
    23149 Commerce Dr
    City
    Farmington Hills
    State
    MI
    Postal Code
    48335
    Country
    US
    Correspondent
    Corinn Moore

    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Prosthesis, Intervertebral Disc MJO
    Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained LZJ
    Pin, Fixation, Threaded JDW

    Proprietary Names

    Ovation Redapt 4.75 MAS 10.5 x110 HA Coated 4.75 MAS 6.5 x 30,35,40,45,50,55,60 HA Coated 4.75 MAS 5.5 x 25,30,35,40,45,50,55 HA Coated 4.75 MAS 7.5 x 25,30,35,40,45,50,55,60,70 HA Coated 4.75 MAS 8.5 x 25,30,35,40,45,50,55,95 HA Coated Screw Short Post 4.5 X 20 TI Screw Short Post 8.5 x 60 TI Screw Short Post 6.5 x 30 TI Screw Short Post 4.5 x 20TI Screw Short Post 4.5 x 25 TI Alpine CDH HA Coated CAMM MAS 5.5 x 25,30,35,40,45,50,55,60,65,70 / 6.5 x 25,30,35,40,45,50,55,60,65, CDH HA Coated MAS 5.5 x 25,30,35,40,45,50,55,60 / 6.5 x 25,30,35,40,45,50,55,60,65 / 7.5 x 25,30,35,40,45,50,55,60,65,70 CDH HA Coated MAS 8.5 x 25,30,35,40,45,50,55,60,65 CHD HA Coated CANN MAS 7.5 x 25,30,35,40,45,50,55,60,65 / 8.5 x 30,35,40,45,50,55,60,65 Anthology 5.5/6 MAS 8.5 x 35,40,45,50 HA Coated 5.5/6 MAS 5.5 x 30,35,40,45,50 HA Coated 5.5/6 MAS 6.5 x 30,35,40,45,50,55 HA Coated 5.5/6 MAS 7.5 x 40,45,50,55 HA Coated Trivicta Legion Echelon Escalade Genesis II Vantage Total Ankle Flat Cut Talar Component Movement Great Toe System HA Screw Short Post 6.5 x 20,25,30,35,40,45,50,55,60 HA Screw Short Post 5.5 x 20,25,30,35,40,45,50,55,60 HA Screw Short Post 7.5 x 20,25,30,35,40,45,50,55,60 HA Screw Short Post 8.5 x 20,25,30,35,40,45,50,55,60 HA Screw Short Post 4.5 x 20,25,30,35,40,45,50,55,60 10.5 x 110 MAS Assembly for 4.75 ROD 7.5 x 90 MAS Assembly for 4.75 ROD 8.5 x 55 MAS Assembly for 4.75 ROD 4 x 35 MAS Assembly for 4.75 ROD Arthrosurface Total Toe - Proximal Phalanx Implant Jet-X

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)