FX V135

GUDID 00840452402430

FX Shoulder Solutions, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840452402430
NIH Device Record Key0f50df79-e0da-4343-be33-711a9db6339f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX V135
Version Model Number950-1812
Company DUNS115052068
Company NameFX Shoulder Solutions, Inc.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840452402430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


[00840452402430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-04
Device Publish Date2025-07-25

On-Brand Devices [FX V135]

00840452402492STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+12
00840452402478STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+6
00840452402461STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+3
00840452402454STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+18
00840452402447STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+15
00840452402430950-1812
00840452402423STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+9
00840452402416STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+6
00840452402409STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+3

Trademark Results [FX V135]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FX V135
FX V135
97481531 not registered Live/Pending
FX SOLUTIONS
2022-06-29

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