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) (2) Orthopedic Manual Surgical Instrument (LXH) (1) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (1)

Premarket Exempt

No Yes

Clear

Catalyst CSR Shoulder System - 00851388006890 Catalog Number :

Device Description : 3-Peg Sizing Template, Large

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

Catalyst CSR Shoulder System - 00851388006944 Catalog Number :

Device Description : Full Instrument Tray

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00851388006975 Catalog Number :

Device Description : Sterile Humeral Cut Guide Fixation Kit

Device Class : 1

Duns Number: 079702565

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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