U-KneeTec MVV661

GUDID 05056139230332

Spacer 11 - 17 mm

CORIN LTD

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID05056139230332
NIH Device Record Keyde28a888-4aa6-471f-ae25-c2f37a171084
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-KneeTec
Version Model NumberMVV661
Catalog NumberMVV661
Company DUNS295437313
Company NameCORIN 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330456608978
Emailseverine.siracusa@coringroup.c
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com
Phone+330456608978
Emailseverine.siracusa@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056139230332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


[05056139230332]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-28
Device Publish Date2018-08-28

On-Brand Devices [U-KneeTec]

05056139230516Femoral clamp
05056139230509Universal handle
05056139230493Handle for punch
05056139230486Femoral bone punch
05056139230479Protective tibial plate
05056139230462Trial femoral component S4
05056139230455Trial femoral component S3
05056139230448Trial femoral component S2
05056139230431Trial femoral component S1
05056139230424Trial femoral component S0
05056139230417AO Müller saw blade
05056139230400Aesculap saw blade
05056139230394Stryker B saw blade
05056139230387Zimmer saw blade
05056139230370Pin driver quick connect
05056139230363Self tapered screw Dia. 3mm L. 40mm
05056139230356Self tapered screw Dia. 3mm L. 25mm
05056139230349Drill bit Ø 8 x 150 mm
05056139230332Spacer 11 - 17 mm
05056139230325Spacer 9 - 15 mm
05056139230318Extramedullary rod
05056139230301Tibial resection gauge
05056139230295Posterior condyle stylus
05056139230288Tbial stylus
05056139230271Distal cutting guide
05056139230264Tibial cutting guide Lat L/Med R
05056139230257Tibial cutting guide Med L/Lat R
05056139230240Fin conformator S4
05056139230233Fin conformator S3
05056139230226Fin conformator S2
05056139230219Fin conformator S1
05056139230202Fin conformator S0
05056139230196Posterior condyle cutting guide S4 Med L/Lat R
05056139230189Posterior condyle cutting guide S3 Med L/Lat R
05056139230172Posterior condyle cutting guide S2 Med L/Lat R
05056139230165Posterior condyle cutting guide S1 Med L/Lat R
05056139230158Posterior condyle cutting guide S0 Med L/Lat R
05056139230141Posterior condyle cutting guide S4 Lat L/Med R
05056139230134Posterior condyle cutting guide S3 Lat L/Med R
05056139230127Posterior condyle cutting guide S2 Lat L/Med R
05056139230110Posterior condyle cutting guide S1 Lat L/Med R
05056139230103Posterior condyle cutting guide S0 Lat L/Med R
05056139230097Augment distal cutting guide 4 mm
05056139230080Augment distal cutting guide 3 mm
05056139230073Augment distal cutting guide 2 mm
05056139230066Augment distal cutting guide 1 mm
05056139230059Mini spacer 3 mm
05056139230042Mini spacer 2 mm
05056139230035Mini spacer 1 mm
05056139225437Cutting pin Ø3mm x 75mm

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