Integra® NuGrip®

GUDID M268NUGRIPINSTP1

The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This set includes trials to evaluate the size and fit of the implant. Instruments are included for assistance.

Ascension Orthopedics, Inc.

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268NUGRIPINSTP1
• NIH Device Record Key: 36ad367f-6357-44c2-960a-a2983a55765f
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® NuGrip®
• Version Model Number: NUGRIPINSTP
• 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	10381780235019 [Primary]
HIBCC	M268NUGRIPINSTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112278

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

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

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

Moist Heat or Steam Sterilization

[M268NUGRIPINSTP1]

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® NuGrip®]

• 10381780364696: CMC Implant NuGrip Trial Caddy Lid
• M269SHP443S1: The Finishing Shaper is used to shape the implant.
• M269SHP443M1: The Finishing Shaper is used to shape the implant.
• M269SHP443L1: The Finishing Shaper is used to shape the implant.
• M269TRL44340M1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44340L1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44330S1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44330M1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44330L1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44320S1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44320M1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44310S1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M269TRL44310M1: The NuGrip Trial is used to evaluate the size and fit of the implant.
• M248CMCCUTRINSTP1: CMC Implant Cutters
• 10381780364689: CMC Implant, NuGrip Trial Caddy
• M268NUGRIPINSTP1: The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cas