LOSPA Mouldar Knee System

GUDID 08800017272801

FEMUR IMPLANT ASM JIG

Corentec Co., Ltd

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08800017272801
NIH Device Record Keyea8cd6d7-d2de-47ad-8d42-53d792f0d64f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA Mouldar Knee System
Version Model NumberKB.SF0.0001
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017272801 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


[08800017272801]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-04
Device Publish Date2026-01-27

Devices Manufactured by Corentec Co., Ltd

08806373887703 - BENCOX Surgical Instruments2026-03-03 Ruler
08809945895021 - EXULT Surgical Instrument2026-03-02 Base, Size 2-4
08809945895038 - EXULT Surgical Instrument2026-03-02 Base, Size 5-8
08809945895045 - EXULT Surgical Instrument2026-03-02 Base, Size 9-11
08809945895052 - EXULT Surgical Instrument2026-03-02 Shim, 10mm
08809945895069 - EXULT Surgical Instrument2026-03-02 Shim, 11mm
08809945895083 - EXULT Surgical Instrument2026-03-02 Shim, 13mm
08809945895090 - EXULT Surgical Instrument2026-03-02 Shim, 14mm

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