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

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 Standard2024-03-06 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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