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E3D-A Interbody System

FDA UDI

Class II (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name
E3D-A Interbody System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, sterile FDA UDI
Device Name
HAnano E3D-A SCREW TROCAR TIP 6.0 X 25mm PACK OF 3 FDA UDI
Model / Reference
110H-60FT25-3 FDA UDI
Description
HAnano E3D-A SCREW TROCAR TIP 6.0 X 25mm PACK OF 3 FDA UDI

Identifiers

Catalog Number
110H-60FT25-3 FDA UDI
Primary DI / UDI-DI
40195860018383 FDA UDI
510(k) Number
K232432 FDA UDI
K240368 FDA UDI
FDA Product Code
MAX FDA UDI
PHM FDA UDI
OVD FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone-screw internal spinal fixation system, sterile

E3D-A Interbody System by Evolution Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, sterile.

Cleared under the same submission

K232432 also covers:

K240368 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Evolution Spine, Llc

Sources (1)

  • FDA UDI 059d54c3-f9f6-4510-afb2-ea895199474a 36 fields · synced Jun 8, 2026