FDA.reportPublic FDA data

EVOLUTION®

Primary DI
00192629249257
Brand
EVOLUTION®
Company
Microport Orthopedics Inc.
Model
E351612L
Catalog number
E351612L
Published
2021-02-11
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629249257PrimaryGS10
M684E351612L1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629249257001926292492571926292492570192629249257

GMDN Terms#

Term, Definition table
TermDefinition
Knee revision femur/tibia prosthesis trialA copy of a final knee revision prosthesis, in the form of combined femoral and tibial components, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
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
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860147Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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