Ensemble CMC 101-CMC-141

GUDID 00810063560003

Ensemble Orthopedics, Inc.

Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis

• Primary Device ID: 00810063560003
• NIH Device Record Key: 4467a7a8-5d7d-4355-a4a0-99bba45113af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ensemble CMC
• Version Model Number: Ensemble CMC Implant, Size 141
• Catalog Number: 101-CMC-141
• Company DUNS: 004115364
• Company Name: Ensemble 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com
• Phone: 512-638-3598
• Email: info@ensembleortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810063560003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201072

FDA Product Code

• KYI: Prosthesis, Wrist, Carpal Trapezium

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [Ensemble CMC]

• 00810063560096: Ensemble Instrument Tray
• 00810063560072: Ensemble CMC Trial, Size 161
• 00810063560065: Ensemble CMC Trial, Size 151
• 00810063560058: Ensemble CMC Trial, Size 141
• 00810063560041: Ensemble CMC Saddle Rasp
• 00810063560034: Ensemble CMC Peripheral Rasp
• 00810063560027: Ensemble CMC Implant, Size 161
• 00810063560010: Ensemble CMC Implant, Size 151
• 00810063560003: Ensemble CMC Implant, Size 141
• 00810063560089: Ensemble CMC Implant Holder
• 00810063560201: Ensemble CMC Bump Rasp