ENOS Software Guided External Fixation System
FDA 510(k) clearance K253764 · decided 2026-02-26
Clearance details
- K-number
- K253764
- Device name
- ENOS Software Guided External Fixation System
- Applicant
- Disior, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-25
- Decision date
- 2026-02-26
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- OSN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Helsinki Uusimaa, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Acute QC Strut and Components (K221792) | Smith & Nephew, Inc. | 2022-08-25 |
| Deformity Analysis and Correction Software (DACS) and Instrumentation (K180539) | Arrowhead Medical Device Technologies, LLC | 2018-08-13 |
| ORTHOHUB EXTERNAL FIXATOR SOFTWARE (K140550) | Orthohub, Inc. | 2014-08-25 |
Recalls involving this device
No recalls on record reference this clearance.