HLS KneeTec GDI064

GUDID 05056139207471

HLS KneeTec fixed tibial insert - Th13mm Size 4

CORIN LTD

Tibial insert

• Primary Device ID: 05056139207471
• NIH Device Record Key: d34471f8-758a-480a-b2d4-349dcff65773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS KneeTec
• Version Model Number: GDI064
• Catalog Number: GDI064
• 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	05056139207471 [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: true

[05056139207471]

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 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