CATALYST ORTHOSCIENCE INC.

Address:14710 Tamiami Trail N., Suite #102,Naples,FL,34110,US

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Filters

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

Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (10) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (2)

Premarket Exempt

No Yes

Clear

Catalyst CSR Shoulder System - 00851388006739 Catalog Number :

Device Description : Humeral Implant, Size H

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006746 Catalog Number :

Device Description : Humeral Implant, Size I

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006777 Catalog Number :

Device Description : 3-Peg Glenoid Implant, Small

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006784 Catalog Number :

Device Description : 3-Peg Glenoid Implant, Medium

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006791 Catalog Number :

Device Description : 3-Peg Glenoid Implant, Large

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006807 Catalog Number :

Device Description : 3-Peg Glenoid Trial, Small

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006814 Catalog Number :

Device Description : 3-Peg Glenoid Trial, Medium

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006821 Catalog Number :

Device Description : 3-Peg Glenoid Trial, Large

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006876 Catalog Number :

Device Description : 3-Peg Sizing Template, Small

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006883 Catalog Number :

Device Description : 3-peg Sizing Template, Medium

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

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