Humeral Cup Standard 312-0703

GUDID 03701037310588

HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3

FX SOLUTIONS

Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup Polyethylene reverse shoulder prosthesis cup
Primary Device ID03701037310588
NIH Device Record Key12386ae9-cd7d-4071-9ed8-db14e9f35955
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumeral Cup Standard
Version Model Number312-0703
Catalog Number312-0703
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

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.
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.
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
GS103701037310588 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

Devices Manufactured by FX SOLUTIONS

03701037319147 - Humeris Shoulder 2024-04-03 Graft Clamp for 3-4 pegs glenoid
03701037320389 - FX V135 Shoulder Prosthesis2024-04-03 Glenoid Manual Reamer Ø40mm
03701037320396 - FX V135 Shoulder Prosthesis2024-04-03 Glenoid Manual Reamer Ø36mm
03701037301043 - Humelock II Cementless Shoulder System2024-03-06 HUMELOCK II STEM TA6V SIZE 10 CEMENTLESS TI/HA
03701037310588 - Humeral Cup Standard2024-03-06HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
03701037310588 - Humeral Cup Standard2024-03-06 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
03701037309476 - Humelock Reversed System2024-03-05 HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm
03701037309483 - Humelock Reversed System2024-03-05 HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm
03701037303740 - HUMELOCK REVERSED2024-02-28 HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA
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