HLS Uni Evolution GDU152

GUDID 05056139208416

HLS uni Evolution Tibial component PE Size 5 Th9mm

CORIN LTD

Uncoated unicondylar knee tibia prosthesis, polyethylene
Primary Device ID05056139208416
NIH Device Record Keye9f61183-585b-4870-b246-ecaa799f7a93
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLS Uni Evolution
Version Model NumberGDU152
Catalog NumberGDU152
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105056139208416 [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 Steriletrue

[05056139208416]

Radiation 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 [HLS Uni Evolution]

05056139233661Pin extractor
05056139225468Tibial trial component forceps
05056139225413Pin Ø 3 x 110 mm
05056139225383Ø 3mm Flat ended drill
05056139225376V alignement jig
05056139225369Malleolar V
05056139225352Malleolar clamp
05056139225345Tibial cutting guide Med L/Lat R
05056139225338Tibial cutting guide Med Right/Lat Left
05056139225321Tibial cutting guide Med Left/Lat Right
05056139225314Tibial cutting guide Med Right/Lat Left
05056139225307Alignement jig for tibial cut
05056139225291Tibial impactor
05056139225284Ø 3mm Drill with stop
05056139225277Ø 8mm Drill bit
05056139225253Condyle cutting guide 4 Med Left/Lat Right
05056139225246Condyle cutting guide 3 Med Left/Lat Right
05056139225239Condyle cutting guide 2 Med Left/Lat Right
05056139225222Condyle cutting guide 1 Med Left/Lat Right
05056139225215Condyle cutting guide 4 Med Right/Lat Left
05056139225208Condyle cutting guide 3 Med Right/Lat Left
05056139225192Condyle cutting guide 2 Med Right/Lat Left
05056139225185Condyle cutting guide 1 Med Right/Lat Left
05056139225178Patellar retractor Med Right/Lat Left
05056139225161Patellar retractor Med Left/Lat Right
05056139225154Pin Ø 3 mm x 40 mm
05056139225147Fixing pin
05056139225130Headed pin Ø 3 mm
05056139225123Femoral bone punch
05056139225116Femoral drilling guide
05056139225109Universal handle
05056139225086Femoral guide for condyle positioning
05056139225079Tibial sizing punch guide size 5
05056139225062Tibial sizing punch guide size 4
05056139225055Tibial sizing punch guide size 3
05056139225048Tibial sizing punch guide size 2
05056139225031Tibial sizing punch guide size 1
05056139225024Tibial punch
05056139224973Saw blade Hall-Linvatec
05056139224966Saw blade Stryker B
05056139224942Trial femoral component N°4 Th.3mm
05056139224935Trial femoral component N°3 Th.3mm
05056139224928Trial femoral component N°2 Th.3mm
05056139224911Trial femoral component N°1 Th.3mm
05056139224881Extraction pin for trial femoral component
05056139224867Pin pusher
05056139224836Saw blade AO Müller
05056139224829Saw blade Aesculap
05056139224782Joint line probe pin
05056139224775Osteotome

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