HLS KneeTec MDI255

GUDID 05056139220111

4 in 1 Cutting Guide S. 5

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: 05056139220111
• NIH Device Record Key: 638bff15-9beb-4748-ad8d-6a1c7fca319b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS KneeTec
• Version Model Number: MDI255
• Catalog Number: MDI255
• 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	05056139220111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K094013

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

Moist Heat or Steam Sterilization

[05056139220111]

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 KneeTec]

• 05056139233685: Hexagonal screwdriver hex 3.5
• 05056139233678: Patellar Impaction System
• 05056139226052: Autodrilling pin dia 3,5mm Lg 50mm
• 05056139225970: Autodrilling pin dia 3,5mm Lg 80mm
• 05056139225017: Oscillating saw blade 1.27mm Stryker B
• 05056139225000: Oscillating saw blade 1.27mm AO Müller
• 05056139224997: Oscillating saw blade 1.27mm Hall-Linvatec
• 05056139224980: Oscillating saw blade 1.27mm Aesculap
• 05056139222337: Fin Impactor Guide 1
• 05056139222320: IM Rod Extraction Handle
• 05056139222313: Cemented stem for punch
• 05056139222306: Fin Impactor Guide 5-6-7-8
• 05056139222290: Fin Impactor Guide 2-3-4
• 05056139222283: Tibial stylus
• 05056139222276: Spacer holder Th. 6mm
• 05056139221613: trial cemented long plug cutter
• 05056139221590: Trial cemented plug cutter
• 05056139221460: 10mm th. Stop
• 05056139221453: 5mm th. Stop
• 05056139221446: Stem reamer
• 05056139221422: Fin Impactor 5-6-7-8
• 05056139221415: Fin Impactor 2-3-4
• 05056139221408: Fin Impactor 1
• 05056139221392: Threaded pins dia 3,5mm Length 50mm
• 05056139221385: 4 in 1 Cutting Guide S.7
• 05056139221378: 4 in 1 Cutting Guide S.6
• 05056139221361: 4 in 1 Cutting Guide S.5
• 05056139221354: 4 in 1 Cutting Guide S.4
• 05056139221347: 4 in 1 Cutting Guide S.3
• 05056139221330: 4 in 1 Cutting Guide S.2
• 05056139221040: Patella ring L
• 05056139221033: Patella ring M
• 05056139221026: Patella ring Small
• 05056139221019: Patella ring X-Small
• 05056139221002: Patella drill guide
• 05056139220999: Patellar Reamer Blade Ø42
• 05056139220982: Pin puller
• 05056139220975: Pin extractor
• 05056139220968: Posterior ref. drill guide
• 05056139220951: Anterior ref. drill guide
• 05056139220944: Gap gauge
• 05056139220937: Sizing guide Left
• 05056139220920: Sizing guide Right
• 05056139220913: Distraction plate
• 05056139220906: Distal Cutting Guide Support MIS
• 05056139220890: Distal Cutting Guide MIS
• 05056139220883: Cutting Pin dia 3,5mm Length 100mm
• 05056139220876: Osteotome
• 05056139220869: Impactor Handle
• 05056139220852: Distal Cutting Guide on Pins