Shoulder Options, Inc.

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

No

Clear

CRP™ Cuff Repair Plate System - 00815482020008 Catalog Number : 01-IM-CP001

Device Description : CRP Plate, Right

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020015 Catalog Number : 02-IM-CP002

Device Description : CRP Plate, Left

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020022 Catalog Number : 45-IM-AB050

Device Description : Anchor Bolt, 50mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020039 Catalog Number : 45-IM-AB045

Device Description : Anchor Bolt, 45mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020046 Catalog Number : 45-IM-AB040

Device Description : Anchor Bolt, 40mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020053 Catalog Number : 45-IM-AB035

Device Description : Anchor Bolt, 35mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020060 Catalog Number : 45-IM-AB030

Device Description : Anchor Bolt, 30mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020077 Catalog Number : 45-IM-AB025

Device Description : Anchor Bolt, 25mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020084 Catalog Number : 45-IM-AB020

Device Description : Anchor Bolt, 20mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

CRP™ Cuff Repair Plate System - 00815482020091 Catalog Number : 45-IM-AB015

Device Description : Anchor Bolt, 15mm

Device Class : 2

Duns Number: 053545528

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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