FDA.reportPublic FDA data

canturio™te Impaction Sleeve

Primary DI
00850015699061
Brand
canturio™te Impaction Sleeve
Company
Canary Medical USA LLC
Model
43-5399-001-14
Device description
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.
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
00850015699061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015699061008500156990618500156990610850015699061

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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
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
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
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
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