RX-FIX

GUDID 00840420170613

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00840420170613
NIH Device Record Key054a9397-8fee-48d8-b690-6d6080540b95
Commercial Distribution StatusIn Commercial Distribution
Brand NameRX-FIX
Version Model Number03-5003
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, 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 Usetrue
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

Customer Support Contacts

Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840420170613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


[00840420170613]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-15

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

00889797104159 - N/A2024-10-21 Procedure Pack Sterile
00889797109802 - N/A2024-10-15 SOLO™ Proximal Guide Block
00889797109819 - N/A2024-10-15 SOLO™ Corner Removal Guide
00889797103923 - PROstep MIS2024-09-23 Chamfer Screw
00889797106351 - Made-To-Order2024-09-11 Swanson Toe Grommet Seater
00889797107433 - Made-To-Order2024-09-11 Inbone® Strike Rod
00889797107457 - Made-To-Order2024-09-11 Inbone® Strike Rod
00889797107471 - Made-To-Order2024-09-11 Cartilage Removal Tool

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.