Cadence™

GUDID M268102041201

Cadence Tibial Trial is used to verify proper implant placement and sizing.

Ascension Orthopedics, Inc.

Ankle prosthesis trial, reusable

• Primary Device ID: M268102041201
• NIH Device Record Key: bdaa7390-af70-4ef2-bdee-6b53466c8368
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cadence™
• Version Model Number: 10204120
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780240617 [Primary]
HIBCC	M268102041201 [Secondary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

[M268102041201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2023-05-03
• Device Publish Date: 2016-08-24

On-Brand Devices [Cadence™]

• M268102031961: U-Joint is used to remove the Tibial Tray from the talus when the Slap Hammer is not sufficient.
• M268102030281: Cadence Talar Implant Extractor is used to remove the Talar Dome implant from the implant site.
• M268102030071: Cadence Insert Inserter is used to properly insert and position the insert implant on the anteri
• M268102095421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102095261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102094261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M28102093401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093371: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093361: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093321: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093311: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093301: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093291: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093281: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093271: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102093261: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092421: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092411: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092401: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092391: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl
• M268102092381: The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidl