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

Shoulder Prosthesis, Reverse Configuration (PHX) (10)

Premarket Exempt

No Yes

Clear

R1 Reverse Shoulder System - 00811596030469 Catalog Number :

Device Description : Poly Insert 36mm +8

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030476 Catalog Number :

Device Description : Poly Insert 36mm +12

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030483 Catalog Number :

Device Description : Poly Insert 40mm +0

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030490 Catalog Number :

Device Description : Poly Insert 40mm +4

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030506 Catalog Number :

Device Description : Poly Insert 40mm +8

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030513 Catalog Number :

Device Description : Poly Insert 40mm +12

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030520 Catalog Number :

Device Description : Standard Baseplate

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030537 Catalog Number :

Device Description : Augmented Baseplate 10°

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030544 Catalog Number :

Device Description : Center Screw 6.5mm - 20mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

R1 Reverse Shoulder System - 00811596030551 Catalog Number :

Device Description : Center Screw 6.5mm - 30mm

Device Class : 2

Duns Number: 079702565

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

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