HLS Noetos Revision GDF553

GUDID 05056139202339

HLS Noetos Revision Femoral component PS Left Size 3

CORIN LTD

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 05056139202339
• NIH Device Record Key: 736fd7d5-ec7a-4d87-8a8e-71d0a709a250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Noetos Revision
• Version Model Number: GDF553
• Catalog Number: GDF553
• 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.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139202339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032079

FDA Product Code

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

Sterilization

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

[05056139202339]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-08-28

On-Brand Devices [HLS Noetos Revision]

• 05056139233302: HLS Noets Revision Extended stem L150mm D22mm
• 05056139233296: HLS Noets Revision Extended stem L150mm D20mm
• 05056139233289: HLS Noets Revision Extended stem L75mm D22mm
• 05056139233272: HLS Noets Revision Extended stem L75mm D20mm
• 05056139218347: Trial stem extension Ø18mm L.50mm
• 05056139218330: Trial stem extension Ø16mm L.50mm
• 05056139218323: Trial stem extension Ø14mm L.50mm
• 05056139218316: Trial stem extension Ø12mm L.50mm
• 05056139218309: Trial stem extension Ø10mm L.50mm
• 05056139217319: Cutting guide support stem
• 05056139217241: Stem femoral adaptor key N°6
• 05056139217234: Stem femoral adaptor key N°5
• 05056139217227: Stem femoral adaptor key N°4
• 05056139217210: Stem femoral adaptor key N°3
• 05056139217203: Stem femoral adaptor key N°2
• 05056139217197: Stem femoral adaptor key N°1
• 05056139217180: Stem assembly key Ø10-18mm
• 05056139217166: Finless tibial punch sizes 3-4-5-6
• 05056139217159: Finless tibial punch sizes 1-2
• 05056139217142: 3.5 mm headed pin
• 05056139217135: Tibial component adaptor S3-4-5-6
• 05056139217128: Tibial component adaptor S1-2
• 05056139217111: Augment feeler height 12mm
• 05056139217104: 4.5mm univ. screwdriver across flat
• 05056139217098: 2.5mm universal screwdriver across flat
• 05056139217081: Augment feeler height 8mm
• 05056139217074: Augment feeler height 4mm
• 05056139217067: Trial flange 9° Left
• 05056139217050: Trial flange 7° Left
• 05056139217043: Trial flange 5° Left
• 05056139217036: Trial flange 9° Right
• 05056139217029: Trial flange 7° Right
• 05056139217012: Trial flange 5° Right
• 05056139217005: Trial sledge 9°
• 05056139216992: Trial sledge 7°
• 05056139216985: Trial sledge 5°
• 05056139216978: Trial femoral stem bridge size 6
• 05056139216961: Trial femoral stem bridge size 5
• 05056139216954: Trial femoral stem bridge size 4
• 05056139216947: Trial femoral stem bridge size 3
• 05056139216930: Trial femoral stem bridge size 2
• 05056139216923: Trial femoral stem bridge size 1
• 05056139216916: Trial Femoral Posterior Augment S5-6 H8mm
• 05056139216909: Trial Femoral Posterior Augment S2-3-4 H8mm
• 05056139216893: Trial Femoral Posterior Augment S1 H8mm
• 05056139216886: Trial Femoral Posterior Augment S5-6 H4mm
• 05056139216879: Trial Femoral Posterior Augment S2-3-4 H4mm
• 05056139216862: Trial Femoral Posterior Augment S1 H4mm
• 05056139216855: Trial Femoral Distal Augment S5-6 H12mm
• 05056139216848: Trial Femoral Distal Augment S2-3-4 H12mm