FDA.reportPublic FDA data

SWANSON

Primary DI
00840420189868
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
4460150
Catalog number
4460150
Device description
Flex Hinge Toe Sizer, Lateral
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
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
00840420189868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420189868008404201898688404201898680840420189868

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
807201207
Device count
1
DM exempt
true
Premarket exempt
true
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
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797102353PROPHECY™ INFINITY™PROPINFFPROPINFF2022-05-25
00889797057110PROPHECY INBONEPROPINBPROPINB2016-10-27
00889797057134PROPHECY INFINITYPROPINFPROPINF2016-10-27
00840420185662PROPHECYPROPRPTPROPRPT2017-03-20
00840420194725PROPHECY INVISIONPROPINVPROPINV2018-02-14
00889797103695PROSTEP™ MICA™57790009577900092022-02-01
00889797103718PROSTEP™ MICA™57790011577900112022-02-01
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
10885862015815NAExactech, Inc.HWT2022-10-04
10885862015822NAExactech, Inc.HWT2022-10-04
10885862015839NAExactech, Inc.HWT2022-10-04
10885862015846NAExactech, Inc.HWT2022-10-04
10885862015853NAExactech, Inc.HWT2022-10-04
10885862015860NAExactech, Inc.HWT2022-10-04
10885862015877NAExactech, Inc.HWT2022-10-04
10885862015884NAExactech, Inc.HWT2022-10-04
10885862015891NAExactech, Inc.HWT2022-10-04
10885862015907NAExactech, Inc.HWT2022-10-04
10885862015914NAExactech, Inc.HWT2022-10-04
10885862015921NAExactech, Inc.HWT2022-10-04
10885862015938NAExactech, Inc.HWT2022-10-04
10885862015945NAExactech, Inc.HWT2022-10-04
10885862015952NAExactech, Inc.HWT2022-10-04
10885862015969NAExactech, Inc.HWT2022-10-04
10885862015976NAExactech, Inc.HWT2022-10-04