Humelock Cemented Shoulder System

GUDID 03701037300510

OFFSET HEAD CoCr 50x20

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 Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis
Primary Device ID03701037300510
NIH Device Record Key0d847b9a-1d2f-44b0-828d-d0b7381d998e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock Cemented Shoulder System
Version Model Number106-5000
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037300510 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

Devices Manufactured by FX SOLUTIONS

03701037320457 - FX V135 Shoulder Prothesis2024-07-10 GLENOID REAMER Ø24 Hex 6
03701037320464 - FX V135 Shoulder Prothesis2024-07-10 AXIS WITH ALLEN BALL
03701037320471 - FX V135 Shoulder Prothesis2024-07-10 STRAIGHT TUBE
03701037320488 - FX V135 Shoulder Prothesis 2024-07-10 7,5° BEVELED EXTREMITY
03701037320495 - FX V135 Shoulder Prothesis 2024-07-10 15° BEVELED EXTREMITY
03701037319048 - Full Wedge Lateralized and Augmented Baseplates 2024-05-28 HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm, 7.5° FULL WEDGE, +0mm LATERALIZED
03701037319055 - Full Wedge Lateralized and Augmented Baseplates2024-05-28 HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm, 7.5° FULL WEDGE, +3mm LATERALIZED
03701037319062 - Full Wedge Lateralized and Augmented Baseplates 2024-05-28 HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm, 7.5° FULL WEDGE, +6mm LATERALIZED
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