Toe MotionTM 9P15-PA01-A

GUDID M5289P15PA01A0

Modular Insert, 1.5mm Offset -01 (3.6mm thick)

ARTHROSURFACE INCORPORATED

Total metatarsophalangeal joint prosthesis, modular
Primary Device IDM5289P15PA01A0
NIH Device Record Key7de29360-e83b-4787-86b5-16166866897b
Commercial Distribution StatusIn Commercial Distribution
Brand NameToe MotionTM
Version Model Number9P15-PA01-A
Catalog Number9P15-PA01-A
Company DUNS144666109
Company NameARTHROSURFACE INCORPORATED
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5289P15PA01A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-21
Device Publish Date2015-09-15

On-Brand Devices [Toe MotionTM]

M5289P15S180A0Fixation Component, DF-P
M5289P15PB02A0Modular Insert, 2.5mm Offset -02 (4.6mm thick)
M5289P15PB01A0Modular Insert, 2.5mm Offset -01 (3.6mm thick)
M5289P15PA02A0Modular Insert, 1.5mm Offset -02 (4.6mm thick)
M5289P15PA01A0Modular Insert, 1.5mm Offset -01 (3.6mm thick)
M5289P1501000Insert Delivery Tool, DF-P

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