Excella III-D®

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: Excella III-D® FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Ti 6Al 4V (ELI) FDA UDI
Model / Reference: E3U5555 FDA UDI
Description: Ti 6Al 4V (ELI) FDA UDI

Identifiers

Catalog Number: E3U5555 FDA UDI
Primary DI / UDI-DI: M711E3U55550 FDA UDI
510(k) Number: K140238 FDA UDI
FDA Product Code: NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
KWQ FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

The Excella III-D is a non-sterile, internal spinal fixation device designed for the treatment of spinal instabilities or deformities. This small, threaded implantable rod features a screw head with a drive intended to stabilize segments in the spine. The device is made of Ti 6Al 4V (ELI) and has been available in various types, including pedicle or transfacet, with a slotted, cross, star, or polygonal drive.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
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
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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

K140238 also covers:

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: Innovasis, Inc.

Sources (1)

FDA UDI 620c7100-c417-4b72-8b3b-2a2afb494a10 36 fields · synced Jul 22, 2026