FDA.reportPublic FDA data

Canturio® Smart Extension 14mm (D) x 30mm (H)

Primary DI
00860003118399
Brand
Canturio® Smart Extension 14mm (D) x 30mm (H)
Company
Canary Medical USA LLC
Model
43-5570-030-14
Device description
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronicsand software.
Published
2024-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
QPPImplantable Post-Surgical Kinematic Measurement Knee Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPPImplantable Post-Surgical Kinematic Measurement Knee DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234056000canturio® se (Canturio Smart Extension)Canary Medical USA, LLC2024-04-24QPP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003118399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003118399008600031183998600031183990860003118399

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur stem prosthesisA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117153396
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015699115CanarE Strap43-5570-007-162023-05-17
00850015699061 canturio™te Impaction Sleeve43-5399-001-142021-09-22
00850015699153Home Base Station (Bluetooth)43-5570-001-152024-09-06
00850015699122Canary Clinic Cart43-5570-008-142023-05-17
00850015699139CanarE Charging Cradle43-5570-007-152023-05-17
00860003118344CanarE – Clinic Wearable Device43-5570-007-142023-05-17
00860003118368Canary Clinic Base Station43-5570-005-142023-05-17
00860003118382Clinic Laptop43-5570-003-152023-05-17
00850015699009 canturio™te Cemented Tibia Drill Bit43-5399-058-142021-09-22
00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg.43-5399-051-052021-09-22
00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.43-5399-052-052021-09-22
00850015699030 canturio™te Modular Bracket Stem Provisional1100436132021-09-22
00850015699047 canturio™te Modular Bracket Drill Bit1100436142021-09-22
00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.43-5907-080-272021-09-22
00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.43-5907-080-292021-09-22
00850015699108canturio™ te Modular Bracket, Impaction Sleeve1100445052021-09-22
00860003118351 canturio™te Provisional43-5571-058-142021-09-22
00860003118313Canary OR Base Station / OR PC App / OR Registration43-5570-002-142021-09-22
00860003118320Canary Home Base Station43-5570-001-142021-09-22
00850015699016OR Barcode Scanner43-5570-006-142021-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015699009 canturio™te Cemented Tibia Drill BitCanary Medical USA LLCQPP2021-09-22
00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg.Canary Medical USA LLCQPP2021-09-22
00850015699030 canturio™te Modular Bracket Stem ProvisionalCanary Medical USA LLCQPP2021-09-22
00850015699047 canturio™te Modular Bracket Drill BitCanary Medical USA LLCQPP2021-09-22
00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.Canary Medical USA LLCQPP2021-09-22
00850015699061 canturio™te Impaction SleeveCanary Medical USA LLCQPP2021-09-22
00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.Canary Medical USA LLCQPP2021-09-22
00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.Canary Medical USA LLCQPP2021-09-22
00850015699092 canturio™te Canary Tibial Ext 14x58mm X-Ray TemplateCanary Medical USA LLCQPP2021-09-22
00850015699108canturio™ te Modular Bracket, Impaction SleeveCanary Medical USA LLCQPP2021-09-22
00860003118306 canturio™teCanary Medical USA LLCQPP2021-09-22
00860003118351 canturio™te ProvisionalCanary Medical USA LLCQPP2021-09-22