HLS Uni Evolution MDU124

GUDID 05056139224515

Tibial Trial N°2 H11mm Med R/Lat L

CORIN LTD

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 05056139224515
• NIH Device Record Key: f98ff0e5-28ba-476e-bdaa-cb65c9b6acdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Uni Evolution
• Version Model Number: MDU124
• Catalog Number: MDU124
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330456608978
• Email: severine.siracusa@coringroup.c
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com
• Phone: +330456608978
• Email: severine.siracusa@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139224515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022211

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

[05056139224515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [HLS Uni Evolution]

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