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ENOS Software Guided External Fixation System 1

by Disior, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06429810209061 UDI-DI Date2 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ENOS Software Guided External Fixation System
Generic Name
External orthopaedic fixation system treatment-plan generation software
Model / Ref / Catalog
1, P45-221-HEXA
Primary DI / UDI-DI
06429810209061
510(k) Number
FDA Product Code
OSN
GMDN Term
External orthopaedic fixation system treatment-plan generation software
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution

Other devices from Disior, Ltd.

See all devices from Disior, Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No