Humelock Cemented Shoulder Prosthesis 106-4600

GUDID 03701037300497

Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 46x18

FX SOLUTIONS

Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis
Primary Device ID03701037300497
NIH Device Record Keya1ddcdbb-e97e-493d-b7d4-a0d2b670ab3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock Cemented Shoulder Prosthesis
Version Model Number106-4600
Catalog Number106-4600
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 Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 Millimeter
Outer Diameter46 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
GS103701037300497 [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 Cemented Shoulder Prosthesis]

03701037306994TRIAL OFFSET HEAD 48x19
03701037306987TRIAL OFFSET HEAD 41x16
03701037306970TRIAL OFFSET HEAD 35x15
03701037306963TRIAL CENTERED HEAD 54X20
03701037306956TRIAL CENTERED HEAD 48x18
03701037306949TRIAL CENTERED HEAD 41x15
03701037306932TRIAL CENTERED HEAD 35x14
03701037305546HUMELOCK RETROVERSION STEM
03701037303634TRIAL OFFSET HEAD 50x20
03701037303627TRIAL OFFSET HEAD 46x18
03701037303603TRIAL OFFSET HEAD 39x15
03701037303597TRIAL CENTERED HEAD 50x19
03701037303580TRIAL CENTERED HEAD 46x17
03701037303573TRIAL CENTERED HEAD 43x16
03701037303566TRIAL CENTERED HEAD 39x14
03701037300497Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 46x18
03701037300480OFFSET HEAD CrCo 43x17
03701037300466Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 39x15
03701037300435Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 50x19
03701037300411Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17
03701037300404Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 43x16
03701037300381Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 39x14
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.