FDA.reportPublic FDA data

Evolution

Primary DI
M684E400TR451
Brand
Evolution
Company
Microport Orthopedics Inc.
Model
E400TR45
Catalog number
E400TR45
Device description
EVOLUTION TIBIAL CONES TIBIAL PREP INSTRUMENT TRAY
Published
2024-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629410848PrimaryGS10
M684E400TR451SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629410848001926294108481926294108480192629410848

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925089NASmith & Nephew, Inc.FSM2026-07-14
10889950157562Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-13
10889950157579Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-13
00889929072400NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCFSM2026-07-10
07640177821393Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821409Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821416Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
G079IVA22025000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
G079IVA22026000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23