Integra® BioMotion® Cannulated Hemi System HM1500

GUDID 10381780116356

The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannulated Hemi System as a partial joint replacement for the first metatarsophalangeal joint (MPJ). The Cannulated Implants are made from Titanium Alloy (ASTM F-136).

Ascension Orthopedics, Inc.

Total metatarsophalangeal joint prosthesis, one-piece
Primary Device ID10381780116356
NIH Device Record Key33dc1fa4-b13e-49b6-9bf9-70fe1d90e438
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra® BioMotion® Cannulated Hemi System
Version Model NumberHM1500
Catalog NumberHM1500
Company DUNS942377524
Company NameAscension Orthopedics, 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 Datefalse
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)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780116356 [Primary]
HIBCCM268HM15001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


[10381780116356]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-21
Device Publish Date2017-10-09

On-Brand Devices [Integra® BioMotion® Cannulated Hemi System]

10381780116394The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
10381780116387The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
10381780116370The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
10381780116363The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
10381780116356The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
M268BIOMOTIONIMP1The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first

Trademark Results [Integra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRA
INTEGRA
98465614 not registered Live/Pending
Cleveland-Cliffs Inc.
2024-03-25
INTEGRA
INTEGRA
98382495 not registered Live/Pending
Universal Instruments Corporation
2024-01-30
INTEGRA
INTEGRA
98155011 not registered Live/Pending
Integra Mission Critical, LLC
2023-08-29
INTEGRA
INTEGRA
97870354 not registered Live/Pending
CROWN PACKAGING TECHNOLOGY, INC.
2023-04-03
INTEGRA
INTEGRA
97711737 not registered Live/Pending
Honda Motor Co., Ltd.
2022-12-09
INTEGRA
INTEGRA
97640152 not registered Live/Pending
Integra LifeSciences Corporation
2022-10-20
INTEGRA
INTEGRA
97636638 not registered Live/Pending
POLYSOURCE, INC.
2022-10-18
INTEGRA
INTEGRA
97060638 not registered Live/Pending
Nordson Corporation
2021-10-05
INTEGRA
INTEGRA
90894598 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-20
INTEGRA
INTEGRA
90880335 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-12
INTEGRA
INTEGRA
88947894 not registered Live/Pending
Horton Point LLC
2020-06-04
INTEGRA
INTEGRA
88794888 not registered Live/Pending
Interior Design Group
2020-02-12

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