FDA.reportPublic FDA data

GTFx™ Greater Tuberosity Fracture Plate System

Primary DI
00815482020992
Brand
GTFx™ Greater Tuberosity Fracture Plate System
Company
Shoulder Options, Inc.
Model
SO03-3150
Catalog number
SO03-3150
Device description
GTF Guide Plate, Left
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815482020992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815482020992008154820209928154820209920815482020992

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
704-512-0000burgan@shoulderoptions.com

Regulatory Flags#

DUNS number
053545528
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815482020022CRP™ Cuff Repair Plate System45-IM-AB05045-IM-AB0502015-11-02
00815482020039CRP™ Cuff Repair Plate System45-IM-AB04545-IM-AB0452015-11-02
00815482020046CRP™ Cuff Repair Plate System45-IM-AB04045-IM-AB0402015-11-02
00815482020053CRP™ Cuff Repair Plate System45-IM-AB03545-IM-AB0352015-11-02
00815482020060CRP™ Cuff Repair Plate System45-IM-AB03045-IM-AB0302015-11-02
00815482020077CRP™ Cuff Repair Plate System45-IM-AB02545-IM-AB0252015-11-02
00815482020084CRP™ Cuff Repair Plate System45-IM-AB02045-IM-AB0202015-11-02
00815482020091CRP™ Cuff Repair Plate System45-IM-AB01545-IM-AB0152015-11-02
00815482020107CRP™ Cuff Repair Plate System45-IM-AB01045-IM-AB0102015-11-02
00815482020138CRP™ Cuff Repair Plate System16-IN-KW15016-IN-KW1502015-11-02
00815482020220AFT™ Proximal Humerus Fracture Plate SystemSO02-3000SO02-30002015-11-02
00815482020237AFT™ Proximal Humerus Fracture Plate SystemSO02-3001SO02-30012015-11-02
00815482020244AFT™ Proximal Humerus Fracture Plate SystemSO02-3002SO02-30022015-11-02
00815482020251AFT™ Proximal Humerus Fracture Plate SystemSO02-3003SO02-30032015-11-02
00815482020268AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-30SO02-3005-302015-11-02
00815482020275AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-32.5SO02-3005-32.52015-11-02
00815482020282AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-35SO02-3005-352015-11-02
00815482020299AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-37.5SO02-3005-37.52015-11-02
00815482020305AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-40SO02-3005-402015-11-02
00815482020312AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-42.5SO02-3005-42.52015-11-02

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