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, Hemi-, Humeral, Metallic Uncemented (HSD) (9) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (1)

Premarket Exempt

No Yes

Clear

CSR Shoulder System - 00811596030001 Catalog Number :

Device Description : Press-Fit Humeral Implant Size B

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030018 Catalog Number :

Device Description : Press Fit Humeral Implant Size A

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030025 Catalog Number :

Device Description : Press-Fit Humeral Implant Size C

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030032 Catalog Number :

Device Description : Press-Fit Humeral Implant Size D

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030049 Catalog Number :

Device Description : Press-Fit Humeral Size F

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030056 Catalog Number :

Device Description : Press-Fit Humeral Implant Size E

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030063 Catalog Number :

Device Description : Press-Fit Humeral Implant Size G

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030070 Catalog Number :

Device Description : Press-Fit Humeral Size H

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030087 Catalog Number :

Device Description : Press-Fit Humeral Size I

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030117 Catalog Number :

Device Description : Augmented 3-Peg Glenoid Implant - 10°, Size: Small

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

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