BEUDAMED
    FDA Registration Active 🇺🇸 United States

    restor3d, inc.

    Reg #: 3014833750 · FEI: 3014833750 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    26

    Registration Details

    Registration Name
    restor3d, inc.
    Registration Number
    3014833750
    FEI Number
    3014833750
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4001 NC Hwy 54, Suite 2160
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191812
    PMA Number
    H230003

    Owner / Operator

    Firm Name
    restor3d, inc.
    Operator Number
    10058270
    Address
    4001 NC Hwy 54, Suite 3160
    City
    Durham
    State
    NC
    Postal Code
    27709
    Country
    US
    Correspondent
    Brianna Prindle

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Rod, Fixation, Intramedullary And Accessories HSB
    Ankle Fusion Cage SAI
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Shoulder Prosthesis, Reverse Configuration PHX
    Shoulder Arthroplasty Implantation System QHE
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Ankle Arthroplasty Implantation System OYK
    Template HWT
    Bone Wedge PLF
    Prosthesis, Total Talus Replacement, Metal QNN
    Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal QYQ
    Pin, Fixation, Smooth HTY
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Plate, Fixation, Bone HRS

    Proprietary Names

    restor3d Cervical Cage restor3d Cervical Interbody Fusion Device TIDAL Fusion Cage Ossera AFX System restor3d Disposable Instruments, Cervical Cage restor3d Lumbar Interbody Fusion Cage Veritas Reverse Total Shoulder System Velora Acetabular Cup iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System Kinos Axiom Total Ankle System restor3d Reverse Total Shoulder Kinos Axiom PSR System restor3d TiDAL Osteotomy Wedge restor3d TiDAL Wedge restor3d Osteotomy Wedge restor3d Total Talus Replacement OsseoREBAR Nail restor3d MTP Implant restor3d Utility Wedge Kinos Aeros Ankle System restor3d Kinos Axiom Range

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198