FDA.reportPublic FDA data

SWANSON II

Primary DI
00840420130617
Brand
SWANSON II
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
G4880301J
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIGPROSTHESIS, WRIST, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIGProsthesis, Wrist, Constrained, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420130617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420130617008404201306178404201306170840420130617

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist radius prosthesisA sterile implantable device designed to replace the distal end of the radius as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is implanted into radial bone proximally; it interfaces with a polyethylene (PE) spacer distally. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840420130624SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130631SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130648SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130655SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420198860SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420129048SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129055SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129062SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129079SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129086SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15