HLS Uni Evolution GDU126

GUDID 05056139208348

HLS uni Evolution Tibial component PE Size 2 Th13mm

CORIN LTD

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 05056139208348
• NIH Device Record Key: 76aaac89-f3e1-4b8b-be5b-a7168dd02a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Uni Evolution
• Version Model Number: GDU126
• Catalog Number: GDU126
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139208348 [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: true

[05056139208348]

Radiation 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