FDA.reportPublic FDA data

AFT™ Proximal Humerus Fracture Plate System

Primary DI
00815482020312
Brand
AFT™ Proximal Humerus Fracture Plate System
Company
Shoulder Options, Inc.
Model
SO02-3005-42.5
Catalog number
SO02-3005-42.5
Device description
4.5 Malleolar Screw, 42.5mm
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00815482020312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815482020312008154820203128154820203120815482020312

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length42.5Millimeter

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
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
00815482020329AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-45SO02-3005-452015-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02