Humelock II Cementless Shoulder System 106-2000

GUDID 03701037302804

PROTECTOR + SCREW TA6V

FX SOLUTIONS

Shoulder prosthesis screw
Primary Device ID03701037302804
NIH Device Record Key5c34aa76-32d6-40a0-b14c-b1a86f4c387b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock II Cementless Shoulder System
Version Model Number106-2000
Catalog Number106-2000
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.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com
Phone+33474553397
Emailjjmartin@fxsolutions.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037302804 [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 Cementless Shoulder System]

03701037307212HUMELOCK K-WIRE Ø2.0mm L.220mm
03701037305614HUMELOCK STEM HOLDER
03701037305607HUMELOCK SOFT TISSUE HOLDER
03701037304785HUMELOCK II TRIAL STEM T13
03701037303672TRIAL ADAPTER REVERSED 135/145°
03701037303665TRIAL DOUBLE TAPER
03701037303658TRIAL OFFSET HEAD 52x20
03701037303641TRIAL OFFSET HEAD 54x21
03701037302941CORTICAL SCREW TA6V Ø4.5mm L.40mm
03701037302934CORTICAL SCREW TA6V Ø4.5mm L.38mm
03701037302804PROTECTOR + SCREW TA6V
03701037301999CORTICAL SCREW TA6V Ø4.5mm L.32mm
03701037301982CORTICAL SCREW TA6V Ø4.5mm L.30mm
03701037301975CORTICAL SCREW TA6V Ø4.5mm L.28mm
03701037301968CORTICAL SCREW TA6V Ø4.5mm L.26mm
03701037301951CORTICAL SCREW TA6V Ø4.5mm L.24mm
03701037301944CORTICAL SCREW TA6V Ø4.5mm L.22mm
03701037301937CORTICAL SCREW TA6V Ø4.5mm L.20mm
03701037301920CORTICAL SCREW TA6V Ø4.5mm L.18mm
03701037301098HUMELOCK II STEM TA6V SIZE 15 CEMENTLESS TI/HA
03701037301081HUMELOCK II STEM TA6V SIZE 14 CEMENTLESS TI/HA
03701037301074HUMELOCK II STEM TA6V SIZE 13 CEMENTLESS TI/HA
03701037301067HUMELOCK II STEM TA6V SIZE 12 CEMENTLESS TI/HA
03701037302019Humelock II Cementless Shoulder System, CORTICAL SCREW TA6V Ø4.5mm L.36mm
03701037302002CORTICAL SCREW TA6V Ø4.5mm L.34mm
03701037301029HUMELOCK II STEM TA6V SIZE 08 CEMENTLESS TI/HA
03701037301043HUMELOCK II STEM TA6V SIZE 10 CEMENTLESS TI/HA
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