Home GUDID 08800068981486 LOSPA Knee System, EXULT Knee System
Primary DI 08800068981486
Brand LOSPA Knee System, EXULT Knee System
Company Corentec Co., Ltd
Model KA.CPM.0002B
Device description Patella Clamp Stylus
Published 2024-01-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LHX Trousers, Anti-Shock
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LHX Trousers, Anti-Shock Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800068981486 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800068981486 08800068981486 8800068981486
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688739895 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506089589 ELMED INCORPORATED ELMED INCORPORATED LHX 2026-03-13 00198506089596 ELMED INCORPORATED ELMED INCORPORATED LHX 2026-03-13 00885556919620 R3 Smith & Nephew, Inc. LHX 2024-11-06 00885556919613 R3 Smith & Nephew, Inc. LHX 2024-11-04 00191083047300 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047317 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047324 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047331 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047348 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047355 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047362 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047379 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00840343722876 GEN2 SURGIX MEDICAL LLC LHX 2024-06-28 08800017205267 LOSPA Knee System, EXULT Knee System Corentec Co., Ltd LHX 2024-01-12 00840343720537 GEN2 SURGIX MEDICAL LLC LHX 2023-12-15 00840343720957 GEN2 SURGIX MEDICAL LLC LHX 2023-12-15 10889981321390 Specials Seaspine Orthopedics Corporation LHX 2023-12-06 00840343719326 Gen2 SURGIX MEDICAL LLC LHX 2023-11-14 00840343719364 Gen2 SURGIX MEDICAL LLC LHX 2023-11-14 00885556910757 Legion Smith & Nephew, Inc. LHX 2023-09-06 00840019967655 Reform® Ti CT Modular MIS Pedicle Screw System PRECISION SPINE, INC. LHX 2023-08-07 00885556832417 Salto Talaris Total Ankle Prosthesis Smith & Nephew, Inc. LHX 2023-08-02 10889981308315 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308322 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308339 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308346 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308353 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308438 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 00850005827337 GENESIS AWL/TAPPER Genesis Biologics, Inc. LHX 2023-03-16 00885556850794 Cadence Total Ankle System Smith & Nephew, Inc. LHX 2023-02-02
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