Shoulder Options, Inc.

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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

Plate, Fixation, Bone (HRS) (2) Screw, Fixation, Bone (HWC) (2)

Premarket Exempt

Clear

GTFx™ Greater Tuberosity Fracture Plate System - 00815482021005 Catalog Number : SO03-3151

Device Description : GTF Guide Plate, Right

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

GTFx™ Greater Tuberosity Fracture Plate System - 00815482021012 Catalog Number : SO03-3152

Device Description : GTF Guide Handle

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

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