FDA.reportPublic FDA data

EVOLUTION

Primary DI
00192629475212
Brand
EVOLUTION
Company
Microport Orthopedics Inc.
Model
EIS6P13L
Catalog number
EIS6P13L
Device description
EVOLUTION® MP™ CS INSERT SIZE 6+ 13MM LEFT
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629475212PrimaryGS10
M684EIS6P13L1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629475212001926294752121926294752120192629475212

Contacts#

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

Regulatory Flags#

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629475007EVOLUTIONEIS1P11LEIS1P11L2026-11-03
00192629475014EVOLUTIONEIS1P13LEIS1P13L2026-11-03
00192629475021EVOLUTIONEIS1S11LEIS1S11L2026-11-03
00192629475038EVOLUTIONEIS1S13LEIS1S13L2026-11-03
00192629475045EVOLUTIONEIS2P11LEIS2P11L2026-11-03
00192629475052EVOLUTIONEIS2P13LEIS2P13L2026-11-03
00192629475069EVOLUTIONEIS2S11LEIS2S11L2026-11-03
00192629475076EVOLUTIONEIS2S13LEIS2S13L2026-11-03
00192629475083EVOLUTIONEIS3P11LEIS3P11L2026-11-03
00192629475090EVOLUTIONEIS3P13LEIS3P13L2026-11-03
00192629475106EVOLUTIONEIS3S11LEIS3S11L2026-11-03
00192629475113EVOLUTIONEIS3S13LEIS3S13L2026-11-03
00192629475120EVOLUTIONEIS4P11LEIS4P11L2026-11-03
00192629475137EVOLUTIONEIS4P13LEIS4P13L2026-11-03
00192629475144EVOLUTIONEIS4S11LEIS4S11L2026-11-03
00192629475151EVOLUTIONEIS4S13LEIS4S13L2026-11-03
00192629475168EVOLUTIONEIS5P11LEIS5P11L2026-11-03
00192629475175EVOLUTIONEIS5P13LEIS5P13L2026-11-03
00192629475182EVOLUTIONEIS5S11LEIS5S11L2026-11-03
00192629475199EVOLUTIONEIS5S13LEIS5S13L2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475007EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03