HLS Noetos Revision GDF544

GUDID 05056139202285

HLS Noetos Revision Femoral component PS Right Size 4

CORIN LTD

Uncoated knee femur prosthesis, metallic
Primary Device ID05056139202285
NIH Device Record Key67c04bea-7348-4148-bcf6-b5f87dd6df3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLS Noetos Revision
Version Model NumberGDF544
Catalog NumberGDF544
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330456608978
Emailseverine.siracusa@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056139202285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05056139202285]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-08-28

On-Brand Devices [HLS Noetos Revision]

05056139233302HLS Noets Revision Extended stem L150mm D22mm
05056139233296HLS Noets Revision Extended stem L150mm D20mm
05056139233289HLS Noets Revision Extended stem L75mm D22mm
05056139233272HLS Noets Revision Extended stem L75mm D20mm
05056139218347Trial stem extension Ø18mm L.50mm
05056139218330Trial stem extension Ø16mm L.50mm
05056139218323Trial stem extension Ø14mm L.50mm
05056139218316Trial stem extension Ø12mm L.50mm
05056139218309Trial stem extension Ø10mm L.50mm
05056139217319Cutting guide support stem
05056139217241Stem femoral adaptor key N°6
05056139217234Stem femoral adaptor key N°5
05056139217227Stem femoral adaptor key N°4
05056139217210Stem femoral adaptor key N°3
05056139217203Stem femoral adaptor key N°2
05056139217197Stem femoral adaptor key N°1
05056139217180Stem assembly key Ø10-18mm
05056139217166Finless tibial punch sizes 3-4-5-6
05056139217159Finless tibial punch sizes 1-2
050561392171423.5 mm headed pin
05056139217135Tibial component adaptor S3-4-5-6
05056139217128Tibial component adaptor S1-2
05056139217111Augment feeler height 12mm
050561392171044.5mm univ. screwdriver across flat
050561392170982.5mm universal screwdriver across flat
05056139217081Augment feeler height 8mm
05056139217074Augment feeler height 4mm
05056139217067Trial flange 9° Left
05056139217050Trial flange 7° Left
05056139217043Trial flange 5° Left
05056139217036Trial flange 9° Right
05056139217029Trial flange 7° Right
05056139217012Trial flange 5° Right
05056139217005Trial sledge 9°
05056139216992Trial sledge 7°
05056139216985Trial sledge 5°
05056139216978Trial femoral stem bridge size 6
05056139216961Trial femoral stem bridge size 5
05056139216954Trial femoral stem bridge size 4
05056139216947Trial femoral stem bridge size 3
05056139216930Trial femoral stem bridge size 2
05056139216923Trial femoral stem bridge size 1
05056139216916Trial Femoral Posterior Augment S5-6 H8mm
05056139216909Trial Femoral Posterior Augment S2-3-4 H8mm
05056139216893Trial Femoral Posterior Augment S1 H8mm
05056139216886Trial Femoral Posterior Augment S5-6 H4mm
05056139216879Trial Femoral Posterior Augment S2-3-4 H4mm
05056139216862Trial Femoral Posterior Augment S1 H4mm
05056139216855Trial Femoral Distal Augment S5-6 H12mm
05056139216848Trial Femoral Distal Augment S2-3-4 H12mm

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