Home GUDID 00860003118351 canturio™te Provisional
Primary DI 00860003118351
Brand canturio™te Provisional
Company Canary Medical USA LLC
Model 43-5571-058-14
Device description 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.
Published 2021-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00860003118351 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 00860003118351 00860003118351 860003118351 0860003118351
GMDN Terms# Term, Definition table Term Definition Knee tibia prosthesis trial A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117153396 Device count 1 Lot or batch true Serial number true Expiration date on label true Sterilization required before use 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 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 00850015699016 OR Barcode Scanner 43-5570-006-14 2021-09-29
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 00860003118306 canturio™te Canary Medical USA LLC QPP 2021-09-22