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

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (10)

Premarket Exempt

Clear

CRP™ Cuff Repair Plate System - 00815482020107 Catalog Number : 45-IM-AB010

Device Description : Anchor Bolt, 10mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020114 Catalog Number : 00-IN-GG001

Device Description : CRP Guide's Guide, Right

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020121 Catalog Number : 00-IN-GG002

Device Description : CRP Guide's Guide, Left

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020138 Catalog Number : 16-IN-KW150

Device Description : 1.6 x 150mm K-Wire, trocar tip

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020145 Catalog Number : 45-IN-DB145

Device Description : 4.5mm Drill Bit

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020152 Catalog Number : 45-IN-DG001

Device Description : 4.5mm Threaded Drill Guide

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020169 Catalog Number : 00-IN-DG001

Device Description : Depth Gauge

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020176 Catalog Number : 00-IN-GH001

Device Description : CRP Guide's Guide Handle

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020183 Catalog Number : 25-IN-SD001

Device Description : 2.5mm Small Hex Screwdriver with Spring Tip

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020190 Catalog Number : 30-IN-PA235

Device Description : Penetrating Awl

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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