FDA.reportPublic FDA data

AFT™ Proximal Humerus Fracture Plate System

Primary DI
00815482020220
Brand
AFT™ Proximal Humerus Fracture Plate System
Company
Shoulder Options, Inc.
Model
SO02-3000
Catalog number
SO02-3000
Device description
AFT Long Fracture 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
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
00815482020220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815482020220008154820202208154820202200815482020220

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length111.44Millimeter

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
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
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