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Evolution

FDA UDI

Class I (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name
EVOLUTION FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
EVOLUTION® KA OFFSET EM TIBIAL ROD W/ STOP FDA UDI
Model / Reference
E1502040 FDA UDI
Description
EVOLUTION® KA OFFSET EM TIBIAL ROD W/ STOP FDA UDI

Identifiers

Catalog Number
E1502040 FDA UDI
Primary DI / UDI-DI
M684E15020401 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant/instrument assembling device

Evolution by MicroPort Orthopedics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroPort Orthopedics Inc.

Sources (1)

  • FDA UDI 79041e32-ec1d-4ee5-9672-0b972b8ae3d5 35 fields · synced Jun 9, 2026