Shoulder Options, Inc.

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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) (8) Screw, Fixation, Bone (HWC) (8) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (2)

Premarket Exempt

Clear

CRP™ Cuff Repair Plate System - 00815482020206 Catalog Number : 30-IN-CH235

Device Description : Crochet Hook

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020213 Catalog Number : 45-IN-SH001

Device Description : 4.5mm QC/AO Handle

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020220 Catalog Number : SO02-3000

Device Description : AFT Long Fracture Plate, Left

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020237 Catalog Number : SO02-3001

Device Description : AFT Long Fracture Plate, Right

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020244 Catalog Number : SO02-3002

Device Description : AFT Short Fracture Plate, Left

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020251 Catalog Number : SO02-3003

Device Description : AFT Short Fracture Plate, Right

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020268 Catalog Number : SO02-3005-30

Device Description : 4.5 Malleolar Screw, 30mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020275 Catalog Number : SO02-3005-32.5

Device Description : 4.5 Malleolar Screw, 32.5mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020282 Catalog Number : SO02-3005-35

Device Description : 4.5 Malleolar Screw, 35mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AFT™ Proximal Humerus Fracture Plate System - 00815482020299 Catalog Number : SO02-3005-37.5

Device Description : 4.5 Malleolar Screw, 37.5mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

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