FX V135 Shoulder Prothesis

GUDID 03701037320464

AXIS WITH ALLEN BALL

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03701037320464
NIH Device Record Key8d10e701-eee1-4064-8bb8-e819ee3f7c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX V135 Shoulder Prothesis
Version Model Number951-0501
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037320464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


[03701037320464]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-10
Device Publish Date2024-07-02

On-Brand Devices [FX V135 Shoulder Prothesis]

0370103732049515° BEVELED EXTREMITY
037010373204887,5° BEVELED EXTREMITY
03701037320471STRAIGHT TUBE
03701037320464AXIS WITH ALLEN BALL
03701037320457GLENOID REAMER Ø24 Hex 6

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