ENOS Software Guided External Fixation System— 510(k) K253764
Substantially EquivalentDisior, Ltd.
FDA 510(k) clearance K253764 for ENOS Software Guided External Fixation System, Substantially Equivalent on 2026-02-26. Applicant: Disior, Ltd.. Device class: 2.
Summary
Disior's ENOS Software Guided External Fixation System is filed under product code OSN (Software For Diagnosis/Treatment). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
The record lists the applicant location as Helsinki Uusimaa, FL, US. Review took 93 calendar days (November 25, 2025 to February 26, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Disior, Ltd.
- Product code
- Product code OSN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki Uusimaa, FL, US
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