AFT™ Proximal Humerus Fracture Plate System SO02-3008-37.5

GUDID 00815482020664

4.5 Locking Screw, 37.5mm

Shoulder Options, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00815482020664
• NIH Device Record Key: d8d1eea9-c225-4ced-af42-63abe0d43825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFT™ Proximal Humerus Fracture Plate System
• Version Model Number: SO02-3008-37.5
• Catalog Number: SO02-3008-37.5
• Company DUNS: 053545528
• Company Name: Shoulder Options, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com

Device Dimensions

• Length: 37.5 Millimeter
• Length: 37.5 Millimeter
• Length: 37.5 Millimeter
• Length: 37.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815482020664 [Primary]

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00815482020664]

Moist Heat or Steam Sterilization

[00815482020664]

Moist Heat or Steam Sterilization

[00815482020664]

Moist Heat or Steam Sterilization

[00815482020664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-02

On-Brand Devices [AFT™ Proximal Humerus Fracture Plate System]

• 00815482020961: 3.5mm Hex Self-Retaining Handle
• 00815482020954: 2.5mm Hex Self-Retaining Handle
• 00815482020947: Fracture Reduction Forceps
• 00815482020930: 3.5mm Hex Driver Bit - A/O Connection
• 00815482020923: 2.5mm Hex Driver Bit - A/O Connection
• 00815482020916: 4.5mm QC/AO Ratcheting Handle
• 00815482020909: Fracture Reduction Forceps (Verbugge)
• 00815482020893: 3.5mm Hexagonal Screwdriver with handle
• 00815482020886: 2.5mm Hexagonal Screwdriver with handle
• 00815482020879: 3.7 mm Drill Bit
• 00815482020862: 3.0 mm Drill Bit
• 00815482020855: 2.7 mm Drill Bit
• 00815482020848: Distal Depth Gauge
• 00815482020831: Distal Set Screw
• 00815482020824: 3.0 mm Drill Guide, Long
• 00815482020817: 3.7mm Drill Guide
• 00815482020800: 3.0 mm Drill Guide, Short
• 00815482020794: 2.7 mm Drill Guide
• 00815482020787: Proximal Depth Gauge
• 00815482020770: AFT Short Drill Guide Plate, Right
• 00815482020763: AFT Short Drill Guide Plate, Left
• 00815482020756: AFT Long Drill Guide Plate, Right
• 00815482020749: AFT Long Drill Guide Plate, Left
• 00815482020732: 4.5 Locking Screw, 55mm
• 00815482020725: 4.5 Locking Screw, 52.5mm
• 00815482020718: 4.5 Locking Screw, 50mm
• 00815482020701: 4.5 Locking Screw, 47.5mm
• 00815482020695: 4.5 Locking Screw, 45mm
• 00815482020688: 4.5 Locking Screw, 42.5mm
• 00815482020671: 4.5 Locking Screw, 40mm
• 00815482020664: 4.5 Locking Screw, 37.5mm
• 00815482020657: 4.5 Locking Screw, 35mm
• 00815482020640: 4.5 Locking Screw, 32.5mm
• 00815482020633: 4.5 Locking Screw, 30mm
• 00815482020626: 3.5 Non-Locking Screw, 45mm
• 00815482020619: 3.5 Non-Locking Screw, 42.5mm
• 00815482020602: 3.5 Non-Locking Screw, 40mm
• 00815482020596: 3.5 Non-Locking Screw, 37.5mm
• 00815482020589: 3.5 Non-Locking Screw, 35mm
• 00815482020572: 3.5 Non-Locking Screw, 32.5mm
• 00815482020565: 3.5 Non-Locking Screw, 30mm
• 00815482020558: 3.5 Non-Locking Screw, 27.5mm
• 00815482020541: 3.5 Non-Locking Screw, 25mm
• 00815482020534: 3.5 Non-Locking Screw, 22.5mm
• 00815482020527: 3.5 Non-Locking Screw, 20mm
• 00815482020510: 3.5 Locking Screw, 55mm
• 00815482020503: 3.5 Locking Screw, 52.5mm
• 00815482020497: 3.5 Locking Screw, 50mm
• 00815482020480: 3.5 Locking Screw, 47.5mm
• 00815482020473: 3.5 Locking Screw, 45mm