AFT™ Proximal Humerus Fracture Plate System SO02-3006-47.5

GUDID 00815482020480

3.5 Locking Screw, 47.5mm

Shoulder Options, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00815482020480
NIH Device Record Key1747be00-fd1b-4b37-a8ad-1c62644046a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFT™ Proximal Humerus Fracture Plate System
Version Model NumberSO02-3006-47.5
Catalog NumberSO02-3006-47.5
Company DUNS053545528
Company NameShoulder Options, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone704-512-0000
Emailburgan@shoulderoptions.com
Phone704-512-0000
Emailburgan@shoulderoptions.com
Phone704-512-0000
Emailburgan@shoulderoptions.com
Phone704-512-0000
Emailburgan@shoulderoptions.com

Device Dimensions

Length47.5 Millimeter
Length47.5 Millimeter
Length47.5 Millimeter
Length47.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100815482020480 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815482020480]

Moist Heat or Steam Sterilization

[00815482020480]

Moist Heat or Steam Sterilization

[00815482020480]

Moist Heat or Steam Sterilization

[00815482020480]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-11-02

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

008154820209613.5mm Hex Self-Retaining Handle
008154820209542.5mm Hex Self-Retaining Handle
00815482020947Fracture Reduction Forceps
008154820209303.5mm Hex Driver Bit - A/O Connection
008154820209232.5mm Hex Driver Bit - A/O Connection
008154820209164.5mm QC/AO Ratcheting Handle
00815482020909Fracture Reduction Forceps (Verbugge)
008154820208933.5mm Hexagonal Screwdriver with handle
008154820208862.5mm Hexagonal Screwdriver with handle
008154820208793.7 mm Drill Bit
008154820208623.0 mm Drill Bit
008154820208552.7 mm Drill Bit
00815482020848Distal Depth Gauge
00815482020831Distal Set Screw
008154820208243.0 mm Drill Guide, Long
008154820208173.7mm Drill Guide
008154820208003.0 mm Drill Guide, Short
008154820207942.7 mm Drill Guide
00815482020787Proximal Depth Gauge
00815482020770AFT Short Drill Guide Plate, Right
00815482020763AFT Short Drill Guide Plate, Left
00815482020756AFT Long Drill Guide Plate, Right
00815482020749AFT Long Drill Guide Plate, Left
008154820207324.5 Locking Screw, 55mm
008154820207254.5 Locking Screw, 52.5mm
008154820207184.5 Locking Screw, 50mm
008154820207014.5 Locking Screw, 47.5mm
008154820206954.5 Locking Screw, 45mm
008154820206884.5 Locking Screw, 42.5mm
008154820206714.5 Locking Screw, 40mm
008154820206644.5 Locking Screw, 37.5mm
008154820206574.5 Locking Screw, 35mm
008154820206404.5 Locking Screw, 32.5mm
008154820206334.5 Locking Screw, 30mm
008154820206263.5 Non-Locking Screw, 45mm
008154820206193.5 Non-Locking Screw, 42.5mm
008154820206023.5 Non-Locking Screw, 40mm
008154820205963.5 Non-Locking Screw, 37.5mm
008154820205893.5 Non-Locking Screw, 35mm
008154820205723.5 Non-Locking Screw, 32.5mm
008154820205653.5 Non-Locking Screw, 30mm
008154820205583.5 Non-Locking Screw, 27.5mm
008154820205413.5 Non-Locking Screw, 25mm
008154820205343.5 Non-Locking Screw, 22.5mm
008154820205273.5 Non-Locking Screw, 20mm
008154820205103.5 Locking Screw, 55mm
008154820205033.5 Locking Screw, 52.5mm
008154820204973.5 Locking Screw, 50mm
008154820204803.5 Locking Screw, 47.5mm
008154820204733.5 Locking Screw, 45mm
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