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spineEOS 4.1

by Eos Imaging

spineEOS 4.1 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K240582 on 25 Jun 2024 and listed in FDA GUDID since 2 Jul 2024 (UDI-DI 03663999000313), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 Nov 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K240582

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03663999000313 UDI-DI Date2 Jul 2024ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240582 Date25 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240582 decided 25 Jun 2024 Active
  • FDA GUDID UDI-DI 03663999000313 listed 2 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240582
  2. Listed FDA GUDID 03663999000313

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
spineEOS
Generic name
Orthopaedic/craniofacial implantation planning software
Model / reference
4.1
Primary DI / UDI-DI
03663999000313
510(k) Number
FDA product code
LLZ
GMDN term
Orthopaedic/craniofacial implantation planning software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Orthopaedic/craniofacial implantation planning software

Similar devices in this category

Other devices filed under Orthopaedic/craniofacial implantation planning software.

Other devices from Eos Imaging

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    Class II

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    Class II

  • EOS System

    Class II

See all devices from Eos Imaging →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)