CADENCE® 10208114

GUDID 10381780527138

Cadence®Total Ankle System, Flat Cut Talar Dome, Size 4, Right

Ascension Orthopedics, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 10381780527138
• NIH Device Record Key: a21233eb-f2ab-416d-83b7-4cda0922f914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADENCE®
• Version Model Number: 10208114
• Catalog Number: 10208114
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use If Package Is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780527138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201507

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2020-12-08
• Device Publish Date: 2020-11-30

On-Brand Devices [CADENCE®]

• 10381780417132: 45° Tibial Impactor Tip
• 10381780417125: Module for Pins, Drivers, and Accessories
• 10381780417118: Size 5 Tibial Trial - Left
• 10381780417101: Size 4X Tibial Trial - Left
• 10381780417095: Size 4 Tibial Trial - Left
• 10381780417088: Size 3X Tibial Trial - Left
• 10381780417071: Size 3 Tibial Trial - Left
• 10381780417064: Size 2X Tibial Trial - Left
• 10381780417057: Size 2 Tibial Trial - Left
• 10381780417040: Size 1X Tibial Trial - Left
• 10381780417033: Size 1 Tibial Trial - Left
• 10381780417026: Size 5 Tibial Trial - Right
• 10381780417019: Size 4X Tibial Trial - Right
• 10381780417002: Size 4 Tibial Trial - Right
• 10381780416999: Size 3X Tibial Trial - Right
• 10381780416982: Size 3 Tibial Trial - Right
• 10381780416975: Size 2X Tibial Trial - Right
• 10381780416968: Size 2 Tibial Trial - Right
• 10381780416951: Size 1X Tibial Trial - Right
• 10381780416944: Size 1 Tibial Trial - Right
• M248CADENCERESECT1: Cadence Total Ankle Resection Instruments
• M248CADENCEINSERT1: Cadence Trials, Insertion, and Removal Instruments
• M248CADENCERESECT121: Cadence Total Ankle Resection Instruments
• M248CADENCEINSERT121: Cadence Trials, Insertion, and Removal Instruments
• 10381780530176: Surgical Instruments, Generic Case Lid Half Size
• 10381780530169: Cadence®Total Ankle System, Case, Cadence Flat Cut Instruments, Alternate
• 10381780530152: Cadence®Total Ankle System, Case, Cadence Flat Cut Instruments
• 10381780527350: Cadence®Total Ankle System, Talar Flat Cut Guide
• 10381780527343: Cadence®Total Ankle System, 2mm Talar Cut Guide
• 10381780527336: Cadence®Total Ankle System, Talar Flat Cut Drill Guide
• 10381780527329: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 5, Left
• 10381780527312: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 4, Left
• 10381780527305: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 3, Left
• 10381780527299: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 2, Left
• 10381780527282: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 1, Left
• 10381780527268: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 5, Right
• 10381780527251: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 4, Right
• 10381780527244: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 3, Right
• 10381780527237: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 2, Right
• 10381780527220: Cadence®Total Ankle System, Flat Cut Talar Trial, Size 1, Right
• 10381780527206: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 5, Left
• 10381780527190: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 4, Left
• 10381780527183: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 3, Left
• 10381780527176: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 2, Left
• 10381780527169: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 1, Left
• 10381780527145: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 5, Right
• 10381780527138: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 4, Right
• 10381780527121: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 3, Right
• 10381780527114: Cadence®Total Ankle System, Flat Cut Talar Dome, Size 2, Right
• 10381780527107: Cadence® Total Ankle System, Flat Cut Talar Dome, Size 1, Right