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spineEOS

FDA UDI

Class II (US FDA UDI)

by Eos Imaging, Inc.

Identity

Trade Name
spineEOS FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Model / Reference
4.1 FDA UDI

Identifiers

Primary DI / UDI-DI
03663999000313 FDA UDI
510(k) Number
K240582 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

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: Orthopaedic/craniofacial implantation planning software

spineEOS by Eos Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Cleared under the same submission

K240582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eos Imaging, Inc.

Sources (1)

  • FDA UDI e440e2d0-1f23-406a-abb8-c8460dce5a23 33 fields · synced May 30, 2026