Cadence™

Basic Information

• Brand Name: Cadence™
• Primary DI: 10381780240211
• Version / Model: 10203023
• Catalog Number: 10203023
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 6
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 3dd96fbf-6e38-4961-9d88-acb2c4f1a9b1
• Distribution End Date: 2026-12-31

Device Description

Cadence Tibial Cut Guide is used to provide precise cutting of the tibia bone and can be used to provide an initial assessment of the correct tibial implant size to be used.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60826	Custom-made orthopaedic/craniofacial surgical guide	A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M268102030231	HIBCC
Primary	10381780240211	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.4in L x .733in W