FDA.reportPublic FDA data

SWANSON

Primary DI
00840420129093
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
4813001
Catalog number
4813001
Published
2015-10-01
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
KWNPROSTHESIS, WRIST, CARPAL LUNATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWNProsthesis, Wrist, Carpal LunateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864491000SWANSON TITANIUM CARPAL LUNATE IMPLANTDow Corning Wright1987-04-15KWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420129093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420129093008404201290938404201290930840420129093

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist carpus prosthesisA sterile implantable device designed to replace some of the carpal bone complex bearing surfaces 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 hand bone distally; it interfaces with a polyethylene (PE) spacer proximally. 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
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
00885556858721PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858738PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858745PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858752PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858769PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858820PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858837PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858844PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858851PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858868PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
M5288W122217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W123517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152223W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153523W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W950016W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W122217A0HemiCAPITATETMARTHROSURFACE INCORPORATEDKWN2018-04-16
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
10381780116240Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116257Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116264Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116271Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116288Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780235040Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236795Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236801Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236818Integra®Ascension Orthopedics, Inc.KWN2016-08-15