U-KneeTec GDU703

GUDID 05056139204081

U-KneeTec Resecting femoral implant Size 3

CORIN LTD

Uncoated unicondylar knee femur prosthesis

• Primary Device ID: 05056139204081
• NIH Device Record Key: 0555e483-2e61-4f5f-9b46-2175fdada169
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-KneeTec
• Version Model Number: GDU703
• Catalog Number: GDU703
• 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	05056139204081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120262

FDA Product Code

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

Sterilization

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

[05056139204081]

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 [U-KneeTec]

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