Canary Medical USA LLC

Address:2710 Loker Ave. West, Suite 350,Carlsbad,CA,92010,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implantable Post-Surgical Kinematic Measurement Knee Device (QPP) (9) Medical Device Data System (OUG) (1)

Premarket Exempt

No Yes

Clear

canturio™te Cemented Tibia Drill Bit - 00850015699009 Catalog Number :

Device Description : The Canary Medical Drill Bit is used to create the cavity in the patient’s tibia

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

OR Barcode Scanner - 00850015699016 Catalog Number :

Device Description : After the surgery is completed, the OR Barcode Scanner can be used to scan the b

Device Class : 1

Duns Number: 117153396

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. - 00850015699023 Catalog Number :

Device Description : The Canary Medical Tibia Resection Cutting Guide (left or right option) is used

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Modular Bracket Stem Provisional - 00850015699030 Catalog Number :

Device Description : Stem provisional is placed within a tray, held in place by reusable Modular Brac

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Modular Bracket Drill Bit - 00850015699047 Catalog Number :

Device Description : Drill Bit is placed within a tray, held in place by reusable Modular Brackets th

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. - 00850015699054 Catalog Number :

Device Description : The Canary Medical Tibia Resection Cutting Guide (left or right option) is used

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Impaction Sleeve - 00850015699061 Catalog Number :

Device Description : The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument u

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. - 00850015699078 Catalog Number :

Device Description : Tibial Cutting guide is placed within a tray, held in place by reusable Modular

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. - 00850015699085 Catalog Number :

Device Description : Tibial Cutting guide is placed within a tray, held in place by reusable Modular

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

canturio™te Canary Tibial Ext 14x58mm X-Ray Template - 00850015699092 Catalog Number :

Device Description : The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the s

Device Class : 2

Duns Number: 117153396

Premarket Exempt : No

Product Code : QPP

Prescription Use : Yes

Device Count : 1

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