FDA.reportPublic FDA data

canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.

Primary DI
00850015699085
Brand
canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.
Company
Canary Medical USA LLC
Model
43-5907-080-29
Device description
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.
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
00850015699085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015699085008500156990858500156990850850015699085

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

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
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
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
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
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