BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    71
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ConforMIS, Inc.
    Registration Number
    3004153240
    FEI Number
    3004153240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Research Dr
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140423

    Owner / Operator

    Firm Name
    restor3d, Inc.
    Operator Number
    9058483
    Address
    4001 NC-54, Suite 3160
    City
    Durham
    State
    NC
    Postal Code
    27709
    Country
    US
    Correspondent
    Brianna Prindle

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR KRS ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CR KNEE REPLACEMENT ITOTAL TOTAL KNEE REPLACEMENT ITOTAL CR INSTRUMENT SET ITOTAL G2 KRS ITOTAL CRUCIATE RETAINING INSTRUMENT SET ITOTAL IJIG COMPONENTS ITOTAL CR IJIG COMPONENTS ITOTAL G2 IJIG INSTRUMENTS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL G2 CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CR ITOTAL G2 CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL G2 IJIGS ITOTAL CR TOTAL KNEE REPLACEMENT ITOTAL KRS ITOTAL G2 CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING KRS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL CR IJIG INSTRUMENTS ITOTAL CRUCIATE RETAINING IJIGS ITOTAL CR CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL G2 ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING CONFORMIS TOTAL KNEE REPAIR SYSTEM ITOTAL CR INSERT ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL KNEE REPLACEMENT SYSTEM ITOTAL IJIG INSTRUMENTS ITOTAL G2 TOTAL KNEE REPLACEMENT iTotal: Tibial Component Extended Thickness Range ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CRUCIATE RETAINING ITOTAL IJIGS ITOTAL G2 CRUCIATE RETAINING KRS ITOTAL G2 CRUCIATE RETAINING IJIGS ITOTAL CR IJIGS ITOTAL CR CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET ITOTAL CRUCIATE RETAINING TIBIAL TRAY ITOTAL CR IJIG ANCILLARY INSTRUMENTS ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 IJIG ANCILLARY INSTRUMENTS ITOTAL CRUCIATE RETAINING KRS ITOTAL G2 IJIG COMPONENTS ITOTAL ITOTAL CR CRUCIATE RETAINING IJIGS ITOTAL IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE ITOTAL TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS ITOTAL CR CRUCIATE RETAINING ITOTAL KNEE REPLACEMENT ITOTAL G2 KNEE REPLACEMENT SYSTEM ITOTAL CR KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device