SWANSON

Primary DI
00840420121561
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
4260070
Catalog number
4260070
Published
2015-10-15
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
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K780132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K780132000IMPLANT, HINGE TOE, FLEX.Dow Corning Corp. Healthcare Industries Materials1978-02-06KWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420121561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420121561008404201215618404201215610840420121561

GMDN Terms#

Term, Definition table
TermDefinition
Total metatarsophalangeal joint prosthesis, one-pieceA sterile implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

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
00819034029181Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029198Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029211Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124507456Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124508989Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00885556834244Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834268Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834282Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834305Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834329Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834374Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834398Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834411Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834435Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834534Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834558Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834572Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834596Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
08057717550801Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550818Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550825Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550832Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550849Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550856Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550863Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550870Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550887Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550894Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
00840124506138Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506145Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18