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 ID: M269TRL435101
• NIH Device Record Key: 1e1c15dd-4992-4901-a845-42d1ef7d8355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® PyroSphere®
• Version Model Number: TRL43510
• Catalog Number: TRL-435-10
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780236450 [Primary]
HIBCC	M269TRL435101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042690

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-01-01
• Device Publish Date: 2016-08-15

On-Brand Devices [Integra® PyroSphere®]

• M269EXT430011: The PCS Implant Extractor is used to remove implants.
• M269BRH445501: Spherical Burr used to create an opening in the bone.
• M269BRH445401: Spherical Burr used to create an opening in the bone.
• M269BRH445301: Spherical Burr used to create an opening in the bone.
• M269BRH445201: Spherical Burr used to create an opening in the bone.
• M269BRH445101: Spherical Burr used to create an opening in the bone.
• M269TRL435501: Trial used to evaluate the size and fit of the implant.
• M269TRL435401: Trial used to evaluate the size and fit of the implant.
• M269TRL435301: Trial used to evaluate the size and fit of the implant.
• M269TRL435201: Trial used to evaluate the size and fit of the implant.
• M269TRL435101: Trial used to evaluate the size and fit of the implant.
• M248PYRSPHSZINSP1: PyroSphere® Sizer