Integra® TRL-351-20L

GUDID M269TRL35120L1

Modular Radial Head MRH Trial, Ti, Sz. 20L

Ascension Orthopedics, Inc.

Elbow humerus prosthesis trial
Primary Device IDM269TRL35120L1
NIH Device Record Keye31623bc-5f86-493c-9548-5147cf4dc51f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra®
Version Model NumberTRL35120L
Catalog NumberTRL-351-20L
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780236337 [Primary]
HIBCCM269TRL35120L1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


[M269TRL35120L1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-08-27
Device Publish Date2016-08-15

On-Brand Devices [Integra®]

M269PUL0920087011Integra®Surgical Instruments The pin puller is used to slide over objects that have been drille
M269EXT200001Integra®Surgical Instruments The Trial Extractor is used to remove trial implants.
M269EXT100011Integra®Surgical Instruments MCP, Extractor, Implant The Implant Extractor is used to remove im
10381780364870Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-LP Plate
10381780364863Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-GT Plate
10381780364856Proximal Humeral Fracture Plate System Screw Caddy Lid
10381780364849Proximal Humeral Fracture Plate System Screw Caddy Base
10381780364832Proximal Humeral Fracture Plate System Tray Upper
10381780364825Proximal Humeral Fracture Plate System Tray Base
10381780364221Surgical Instruments - 2.0mm K-wire - Threaded
10381780364214Surgical Instruments - 2.0mm K-wire - Smooth
10381780364061Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-GT Plate
10381780364054Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-LP Plate
10381780250548Humeral Resurfacing Arthroplasty Humeral Broach Sz. 3
10381780250531Humeral Resurfacing Arthroplasty Humeral Broach Sz. 2
10381780250524Humeral Resurfacing Arthroplasty Humeral Broach Sz. 1
M2695030042501Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t
M26922042501Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t
M269122250200021Integra® External Fixation System The punch is used for the half pin drill guide in the externa
M269SDGTFS351Integra®Total Foot System The snap-on drill guide is used for precision and accuracy when drill
M269SDGTFS271Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
M269SDGTFS251Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
M269SDGTFS181Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
M269RIGTFS181Integra® Total Foot System The interfrag drill guide right is used for precision and accuracy w
M269LIGTFS181Integra®Total Foot System The interfrag drill guide is used for precision and accuracy when dri
M269LDGTFS251Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill
M269LDGTFS181Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill
M269CDGTFS181Integra® Total Foot System The compression drill guide is used for precision and accuracy when
M2695030035451Integra® Total Foot System The drill guide is used for precision and accuracy when drilling.
M269SCR09200600011Integra®Surgical Instruments The 1/8 Hex Driver is used to tighten or loosen screws.
M269PIN09200510011Integra®Surgical Instruments The fixation pin helps with stabilization.
M269G107992B1Integra®Surgical Instruments The driver handle is provided with a small AO adaptor.
M269G107991B1Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone.
M269MRHRMR031Integra® Modular Radial Head MRH Reamer Sz. 03 The Modular Radial Head Reamer compresses and/
M269MRHRMR021Integra® Modular Radial Head MRH Reamer Sz. 02 The Modular Radial Head Reamer compresses and/
M269MRHRMR011Integra® Modular Radial Head MRH Reamer Sz. 01 The Modular Radial Head Reamer compresses and/
M269MRHPLN001Integra® Modular Radial Head The planar is used with the modular radial head.
M269CCR89502241Integra® Total Foot System Cone Spherical Reamer Sz. 24mm The Cone cannulated reamer is intende
M269CCR89502211Integra® Total Foot System Cone Spherical Reamer Sz. 21mm The Cone cannulated reamer is intende
M269CCR89502191Integra® Total Foot System Cone Spherical Reamer Sz. 19mm The Cone cannulated reamer is intende
M269CCR89502161Integra® Total Foot System Cone Spherical Reamer Sz. 16mm The Cone cannulated reamer is intende
M269CCR89501241Integra® Total Foot System Cup Spherical Reamer Sz. 24mm The Cup cannulated reamer is intended
M269CCR89501211Integra® Total Foot System Cup Spherical Reamer Sz. 21mm The Cup cannulated reamer is intended
M269CCR89501191Integra® Total Foot System Cup Spherical Reamer Sz. 19mm The Cup cannulated reamer is intended
10381780245230Surgical Instruments Driver Handle w/SM AO
10381780533733Surgical Instruments Torque Limiter
M269G108404B1Integra®Surgical Instruments The T-handle is provided with a large AO adaptor.
M269OSG442001Silicone PIP Cut Guide
M269OSG20040PV1PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 40
M269OSG20040P1PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40

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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