Humelock II Cemented Shoulder System 106-4100

GUDID 03701037300473

OFFSET HEAD CrCo 41x16

FX SOLUTIONS

Stem-fixed humeral head prosthesis
Primary Device ID03701037300473
NIH Device Record Key2c660583-162e-4d0b-8a68-3b018e1b33ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock II Cemented Shoulder System
Version Model Number106-4100
Catalog Number106-4100
Company DUNS263076196
Company NameFX SOLUTIONS
Device Count1
DM Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr

Device Dimensions

Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037300473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-07
Device Publish Date2016-06-09

On-Brand Devices [Humelock II Cemented Shoulder System]

03701037307199CANNULATED HEX 3.5 SCREW DRIVER
03701037307182HUMELOCK AIMING GUIDE SCREW
03701037307168TRAUMA IMPACTOR
03701037307137OSTEOTOME
03701037307106HUMELOCK HEIGHT GAUGE AXIS POINT
03701037306864HUMELOCK ANCHORING PLATE IMPACTOR HANDLE
03701037306857HUMELOCK HEAD IMPACTOR BIT
03701037306840HUMELOCK HEAD IMPACTOR HANDLE
03701037306833STABILIZATION POST FORCEPS
03701037306826STABILIZATION POST
03701037306819GLENOID REMOVAL
03701037306796DRILL BIT Ø4.5mm L150mm/ AO
03701037306765GLENOID RESURFACING REAMER Ø39 mm/30 /AO
03701037306758GLENOID RESURFACING REAMER Ø35 mm/30 /AO
03701037306741GLENOID RESURFACING REAMER Ø31 mm/30 /AO
03701037306734GLENOID RESURFACING REAMER Ø27 mm/30 /AO
03701037306536HEX 3,5mm KEY
03701037306529SCREW / RASP HANDLE
03701037306512RASP HANDLE
03701037306468STABILIZATION POST Ø7.5
03701037306451HUMELOCK STAINLESS STEEL RULER L.150
03701037306444HUMELOCK CORTICAL SCREW GAUGE
03701037306383STOP DRILL BIT Ø7.5mm L.150
03701037305805HEAD IMPACTOR
03701037305799TAPER IMPACTOR
03701037305782Ø34 IMPACTOR BIT
03701037305775PUNCHER Ø38mm
03701037305768PUNCHER Ø34mm
03701037305751PUNCHER Ø30mm
03701037305744K-WIRE CENTER GUIDE Ø50 mm
03701037305737K-WIRE CENTER GUIDE Ø46 mm
03701037305720K-WIRE CENTER GUIDE Ø43 mm
03701037305713K-WIRE CENTER GUIDE Ø39 mM
03701037305706EASYTECH SUPERIOR LATERAL CUTTING GUIDE
03701037305690EASYTECH LEFT DELTO PECTORAL CUTTING GUIDE
03701037305683EASYTECH RIGHT DELTO PECTORAL CUTTING GUIDE
03701037305676CENTERING GUIDE
03701037305669K-WIRE GUIDE HANDLE
03701037305652RING CUTTING GUIDE Ø50 mm
03701037305645RING CUTTING GUIDE Ø46 mm
03701037305638RING CUTTING GUIDE Ø43 mm
03701037305621RING CUTTING GUIDE Ø39 mm
03701037305591CUTTING GUIDE HANDLE
03701037305560CUTTING GUIDE SCREW
03701037305553HUMELOCK HEX 6/3.5mmSCREWDRIVER
03701037305515HUMELOCK HEIGHT GAUGE SUPERIOR FLAT
03701037305508THREADED K-WIRE Ø2.0 L180mm
03701037305492K-WIRE Ø2.0mm L.180mm
03701037304808HUMELOCK II TRIAL STEM T15
03701037304792HUMELOCK II TRIAL STEM T14
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