FDA.reportPublic FDA data

SWANSON

Primary DI
00840420129178
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
482303L
Catalog number
482303L
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
KWOPROSTHESIS, WRIST, CARPAL SCAPHOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWOProsthesis, Wrist, Carpal ScaphoidOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864490000SWANSON TITANIUM CARPAL SCAPHOID IMPLANTDow Corning Wright1987-04-15KWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420129178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420129178008404201291788404201291780840420129178

GMDN Terms#

Term, Definition table
TermDefinition
Carpal scaphoid prosthesisA sterile implantable device designed to replace the scaphoid bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
00840493402642RIVA Posterior Fixation SystemXENIX MEDICAL LLCKWO2025-12-08
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00880304481091MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00880304481107MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00880304481114MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00840420121899SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-15
00840420121905SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-15
00840420129130SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129147SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129154SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129161SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129185SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132819SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132826SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132833SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132840SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01