FDA.reportPublic FDA data

EVOLVE

Primary DI
00840420188557
Brand
EVOLVE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
2496S095
Catalog number
2496S095
Device description
Stem Trial
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
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060731000EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc2006-04-19KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420188557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420188557008404201885578404201885570840420188557

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesis trialA copy of a final elbow radius prosthesis designed to be used for trial reductions during elbow arthroplasty to help determine the correct size, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9.5Millimeter

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
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
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840286860154Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860161Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860178Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860185Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860192Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860208Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860215Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860239Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860246Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860253Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860260Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860277Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860284Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860291Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860307Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860314Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860321Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860338Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860345Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860352Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860369Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860376Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860383Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860437Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860451Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860475Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860499Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860512Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860536Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10