Address:2710 Loker Ave. West, Suite 350,Carlsbad,CA,92010,US
Device Description : CTE Instruments are stored in an Instrument Tray which has no contact with the p CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) S 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.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OR Base Station subsystem is intended to send and receive data to and from t The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Device Class : 1
Duns Number: 117153396
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Device Class : 1
Duns Number: 117153396
Premarket Exempt : Yes
Prescription Use : No
Device Description : Dedicated Laptop PC, part of the OR Base Station System
Device Class : 1
Duns Number: 117153396
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes