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) (5)

Premarket Exempt

No Yes

Clear

CSR Shoulder System - 00811596030124 Catalog Number :

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

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030131 Catalog Number :

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

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030148 Catalog Number :

Device Description : 3-Peg Augment Trial - 10°, Size: Small

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030155 Catalog Number :

Device Description : 3-Peg Augment Trial - 10°, Size: Medium

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030162 Catalog Number :

Device Description : 3-Peg Augment Trial - 10°, Size: Large

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030179 Catalog Number :

Device Description : 5.75mm Drill Guide Locking Pin

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030193 Catalog Number :

Device Description : Small Humeral Cover

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : KWT, HSD

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030339 Catalog Number :

Device Description : XS Angled Reamer

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030346 Catalog Number :

Device Description : XXS Angled Reamer

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

CSR Shoulder System - 00811596030353 Catalog Number :

Device Description : XS Humeral Modular Cut Guide 1

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : HSD, KWT

Prescription Use : Yes

Device Count : 1

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