LOSPA Knee System

GUDID 08806373891847

Tibial insert trial-Fixed-CR-SZ 9-26T

Corentec Co., Ltd

Knee tibia prosthesis trial, reusable
Primary Device ID08806373891847
NIH Device Record Key999e4ba4-fbaf-4b11-aba3-3aaa6bfcb3b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA Knee System
Version Model Number01.62.19I
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373891847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


[08806373891847]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2022-03-22
Device Publish Date2018-01-31

On-Brand Devices [LOSPA Knee System]

08806373890086Pin driver
08806373890062Pin holder
08806373889813Tibial reamer
08806373878138Reamer Φ18
08806373878121Reamer Φ17
08806373878114Reamer Φ16
08806373878107Reamer Φ15
08806373878091Reamer Φ14
08806373878084Reamer Φ13
08806373878077Reamer Φ12
08806373878060Reamer Φ11
08806373878053Reamer Φ10
08806373878046Reamer Φ09
08806373875311Offset Reamer ∅18
08806373875304Offset Reamer ∅17
08806373875298Offset Reamer ∅16
08806373875281Offset Reamer ∅15
08806373875274Offset Reamer ∅14
08806373875267Offset Reamer ∅13
08806373875250Offset Reamer ∅12
08806373875243Offset Reamer ∅11
08806373875236Offset Reamer ∅10
08806373875229Offset Reamer ∅9
08806373898570Tibial baseplate trial-Fixed-SZ 16
08806373898563Tibial baseplate trial-Fixed-SZ 14
08806373898556Tibial baseplate trial-Fixed-SZ 12
08806373898549Tibial baseplate trial-Fixed-SZ 6
08806373898532Tibial insert trial-Fixed-PS-SZ 16-26T
08806373898525Tibial insert trial-Fixed-PS-SZ 16-24T
08806373898518Tibial insert trial-Fixed-PS-SZ 16-22T
08806373898501Tibial insert trial-Fixed-PS-SZ 16-20T
08806373898495Tibial insert trial-Fixed-PS-SZ 16-18T
08806373898488Tibial insert trial-Fixed-PS-SZ 16-16T
08806373898471Tibial insert trial-Fixed-PS-SZ 16-14T
08806373898464Tibial insert trial-Fixed-PS-SZ 16-12T
08806373898457Tibial insert trial-Fixed-PS-SZ 16-10T
08806373898440Tibial insert trial-Fixed-PS-SZ 16-8T
08806373898433Tibial insert trial-Fixed-PS-SZ 14-26T
08806373898426Tibial insert trial-Fixed-PS-SZ 14-24T
08806373898419Tibial insert trial-Fixed-PS-SZ 14-22T
08806373898402Tibial insert trial-Fixed-PS-SZ 14-20T
08806373898396Tibial insert trial-Fixed-PS-SZ 14-18T
08806373898389Tibial insert trial-Fixed-PS-SZ 14-16T
08806373898372Tibial insert trial-Fixed-PS-SZ 14-14T
08806373898365Tibial insert trial-Fixed-PS-SZ 14-12T
08806373898358Tibial insert trial-Fixed-PS-SZ 14-10T
08806373898341Tibial insert trial-Fixed-PS-SZ 14-8T
08806373898334Tibial insert trial-Fixed-PS-SZ 12-26T
08806373898327Tibial insert trial-Fixed-PS-SZ 12-24T
08806373898310Tibial insert trial-Fixed-PS-SZ 12-22T

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