Integra® First Choice®

GUDID M268FRSTDRUJINSP1

The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.

Ascension Orthopedics, Inc.

General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268FRSTDRUJINSP1
• NIH Device Record Key: 4f3bc9a3-f0f1-437b-b334-09577b63ad6c
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® First Choice®
• Version Model Number: FRSTDRUJINSP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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	10381780234951 [Primary]
HIBCC	M268FRSTDRUJINSP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112481

FDA Product Code

• KXE: PROSTHESIS, WRIST, HEMI-, ULNAR

Sterilization

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

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

[M268FRSTDRUJINSP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2016-08-15

On-Brand Devices [Integra® First Choice®]

• M269TRL600S651: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600S551: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600S451: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600MED1: The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo
• M269TRL600LNG1: The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo
• M269TRL600H1901: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL600H1751: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL600H1601: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL610H190S651: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H190S451: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H175S651: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H175S551: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M268FRSTDRUJINSP1: The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint