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: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: HAnano E3D-A SCREW BLUNT TIP 6.0 X 20mm PACK OF 2 FDA UDI
Model / Reference: 110H-60FB20-2 FDA UDI
Description: HAnano E3D-A SCREW BLUNT TIP 6.0 X 20mm PACK OF 2 FDA UDI

Identifiers

Catalog Number: 110H-60FB20-2 FDA UDI
Primary DI / UDI-DI: 30195860018324 FDA UDI
510(k) Number: K232432 FDA UDI
K240368 FDA UDI
FDA Product Code: MAX FDA UDI
OVD FDA UDI
PHM FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

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

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Also classified as Spinal bone screw, non-bioabsorbable.

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Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
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AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Evolution Spine, Llc

Sources (1)

FDA UDI 02a6c1f5-eef4-4e70-a5df-e321a19546e2 36 fields · synced Jun 1, 2026