Home GUDID 00860003118306 canturio™te
Primary DI 00860003118306
Brand canturio™te
Company Canary Medical USA LLC
Model 43-5570-058-14
Device description The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Published 2021-09-22
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QPP Implantable Post-Surgical Kinematic Measurement Knee Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPP Implantable Post-Surgical Kinematic Measurement Knee Device Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860003118306 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860003118306 00860003118306 860003118306 0860003118306
GMDN Terms# Term, Definition table Term Definition Knee femur stem prosthesis A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.
Regulatory Flags# DUNS number 117153396 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850015699115 CanarE Strap 43-5570-007-16 2023-05-17 00850015699061 canturio™te Impaction Sleeve 43-5399-001-14 2021-09-22 00860003118399 Canturio® Smart Extension 14mm (D) x 30mm (H) 43-5570-030-14 2024-09-12 00850015699153 Home Base Station (Bluetooth) 43-5570-001-15 2024-09-06 00850015699122 Canary Clinic Cart 43-5570-008-14 2023-05-17 00850015699139 CanarE Charging Cradle 43-5570-007-15 2023-05-17 00860003118344 CanarE – Clinic Wearable Device 43-5570-007-14 2023-05-17 00860003118368 Canary Clinic Base Station 43-5570-005-14 2023-05-17 00860003118382 Clinic Laptop 43-5570-003-15 2023-05-17 00850015699009 canturio™te Cemented Tibia Drill Bit 43-5399-058-14 2021-09-22 00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. 43-5399-051-05 2021-09-22 00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. 43-5399-052-05 2021-09-22 00850015699030 canturio™te Modular Bracket Stem Provisional 110043613 2021-09-22 00850015699047 canturio™te Modular Bracket Drill Bit 110043614 2021-09-22 00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. 43-5907-080-27 2021-09-22 00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. 43-5907-080-29 2021-09-22 00850015699108 canturio™ te Modular Bracket, Impaction Sleeve 110044505 2021-09-22 00860003118351 canturio™te Provisional 43-5571-058-14 2021-09-22 00860003118313 Canary OR Base Station / OR PC App / OR Registration 43-5570-002-14 2021-09-22 00860003118320 Canary Home Base Station 43-5570-001-14 2021-09-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860003118399 Canturio® Smart Extension 14mm (D) x 30mm (H) Canary Medical USA LLC QPP 2024-09-12 00850015699009 canturio™te Cemented Tibia Drill Bit Canary Medical USA LLC QPP 2021-09-22 00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699030 canturio™te Modular Bracket Stem Provisional Canary Medical USA LLC QPP 2021-09-22 00850015699047 canturio™te Modular Bracket Drill Bit Canary Medical USA LLC QPP 2021-09-22 00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699061 canturio™te Impaction Sleeve Canary Medical USA LLC QPP 2021-09-22 00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699092 canturio™te Canary Tibial Ext 14x58mm X-Ray Template Canary Medical USA LLC QPP 2021-09-22 00850015699108 canturio™ te Modular Bracket, Impaction Sleeve Canary Medical USA LLC QPP 2021-09-22 00860003118351 canturio™te Provisional Canary Medical USA LLC QPP 2021-09-22