Integra® PyroSphere® TRL-435-10

GUDID M269TRL435101

Trial used to evaluate the size and fit of the implant.

Ascension Orthopedics, Inc.

Carpometacarpal interpositional spacer prosthesis trial
Primary Device IDM269TRL435101
NIH Device Record Key1e1c15dd-4992-4901-a845-42d1ef7d8355
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra® PyroSphere®
Version Model NumberTRL43510
Catalog NumberTRL-435-10
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 Usefalse
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
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780236450 [Primary]
HIBCCM269TRL435101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYIPROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


[M269TRL435101]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-01-01
Device Publish Date2016-08-15

On-Brand Devices [Integra® PyroSphere®]

M269EXT430011The PCS Implant Extractor is used to remove implants.
M269BRH445501Spherical Burr used to create an opening in the bone.
M269BRH445401Spherical Burr used to create an opening in the bone.
M269BRH445301Spherical Burr used to create an opening in the bone.
M269BRH445201Spherical Burr used to create an opening in the bone.
M269BRH445101Spherical Burr used to create an opening in the bone.
M269TRL435501Trial used to evaluate the size and fit of the implant.
M269TRL435401Trial used to evaluate the size and fit of the implant.
M269TRL435301Trial used to evaluate the size and fit of the implant.
M269TRL435201Trial used to evaluate the size and fit of the implant.
M269TRL435101Trial used to evaluate the size and fit of the implant.
M248PYRSPHSZINSP1PyroSphere® Sizer

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

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