Address:2710 Loker Ave. West, Suite 350,Carlsbad,CA,92010,US
Device Description : The Canary Medical Drill Bit is used to create the cavity in the patient’s tibia The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Device Class : 1
Duns Number: 117153396
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Stem provisional is placed within a tray, held in place by reusable Modular Brac Stem provisional is placed within a tray, 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 : Drill Bit is placed within a tray, held in place by reusable Modular Brackets th Drill Bit is placed within a tray, 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 Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument u The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, 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 : Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, 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 CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the s The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
Device Class : 2
Duns Number: 117153396
Premarket Exempt : No
Prescription Use : Yes