Humelock II Cemented Reversible Shoulder 314-0606

GUDID 03701037302910

HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +6

FX SOLUTIONS

Polyethylene reverse shoulder prosthesis cup
Primary Device ID03701037302910
NIH Device Record Key747802b3-1a4c-4554-8826-e399ad71e9f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock II Cemented Reversible Shoulder
Version Model Number314-0606
Catalog Number314-0606
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

Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 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
GS103701037302910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

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 Reversible Shoulder]

03701037306406DEGENERATIVE IMPACTOR
03701037303559TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +9
03701037303542TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +6
03701037303535TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +3
03701037303528TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +9
03701037303511TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +6
03701037303504TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +3
03701037303498TRIAL HUMERAL CUP 135/145° Ø40+9
03701037303481TRIAL HUMERAL CUP 135/145° Ø40+6
03701037303474TRIAL HUMERAL CUP 135/145° Ø40+3
03701037303467TRIAL ECCENTRIC GLENOSPHERE Ø40
03701037303450TRIAL CENTERED GLENOSPHERE Ø40
03701037303443TRIAL ECCENTRIC GLENOSPHERE Ø36
03701037303436TRIAL CENTERED GLENOSPHERE Ø36
03701037303375STANDARD TRIAL CUP Ø36 + 9
03701037303368STANDARD TRIAL CUP Ø36 + 6
03701037303351STANDARD TRIAL CUP Ø36 + 3
03701037302927HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +9
03701037302910HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +6
03701037302903HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +3
03701037302897HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +9
03701037302880HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +6
03701037302873HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +3
03701037302866HUMERAL CUP MOBILITY PE/TA6V Ø40/+9
03701037302859HUMERAL CUP MOBILITY PE/TA6V Ø40/+6
03701037302842HUMERAL CUP MOBILITY PE/TA6V Ø40/+3
03701037302835HUMERAL CUP MOBILITY PE/TA6V Ø36/+9
03701037302828HUMERAL CUP MOBILITY PE/TA6V Ø36/+6
03701037302811HUMERAL CUP MOBILITY PE/TA6V Ø36/+3
03701037302637STANDARD SCREW TA6V Ø4.5mm L.48 mm
03701037302620STANDARD SCREW TA6V Ø4.5mm L.46 mm
03701037302613STANDARD SCREW TA6V Ø4.5mm L.44 mm
03701037302583STANDARD SCREW TA6V Ø4.5mm L.36 mm
03701037302569STANDARD SCREW TA6V Ø4.5mm L.32 mm
03701037302552STANDARD SCREW TA6V Ø4.5mm L.28 mm
03701037302545STANDARD SCREW TA6V Ø4.5mm L.26 mm
03701037302538STANDARD SCREW TA6V Ø4.5mm L.24 mm
03701037302521STANDARD SCREW TA6V Ø4.5mm L.22 mm
03701037302477LOCKING SCREW TA6V Ø4.5mm L.48 mm
03701037302460LOCKING SCREW TA6V Ø4.5mm L.46 mm
03701037302453LOCKING SCREW TA6V Ø4.5mm L.44 mm
03701037302446LOCKING SCREW TA6V Ø4.5mm L.42 mm
03701037302439LOCKING SCREW TA6V Ø4.5mm L.38 mm
03701037302422LOCKING SCREW TA6V Ø4.5mm L.36mm
03701037302415LOCKING SCREW TA6V Ø4.5mm L.34 mm
03701037302408LOCKING SCREW TA6V Ø4.5mm L.32 mm
03701037302392LOCKING SCREW TA6V Ø4.5mm L.28 mm
03701037302385LOCKING SCREW TA6V Ø4.5mm L.26 mm
03701037302378LOCKING SCREW TA6V Ø4.5mm L.24 mm
03701037302361LOCKING SCREW TA6V Ø4.5mm L.22 mm
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