FDA.reportPublic FDA data

canturio™te Cemented Tibia Drill Bit

Primary DI
00850015699009
Brand
canturio™te Cemented Tibia Drill Bit
Company
Canary Medical USA LLC
Model
43-5399-058-14
Device description
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.
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
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
DEN200064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200064000Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical, Inc.2021-08-27QPP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015699009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015699009008500156990098500156990090850015699009

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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 DIBrandModelCatalogPublished
00850015699115CanarE Strap43-5570-007-162023-05-17
00850015699061 canturio™te Impaction Sleeve43-5399-001-142021-09-22
00860003118399Canturio® Smart Extension 14mm (D) x 30mm (H)43-5570-030-142024-09-12
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
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
00860003118399Canturio® Smart Extension 14mm (D) x 30mm (H)Canary Medical USA LLCQPP2024-09-12
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