510(k) K253764
- Device
- ENOS Software Guided External Fixation System
- Applicant
- Disior, Ltd.
- 510(k) number
- K253764
- Product code
- OSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-26
- Date received
- 2025-11-25
- Regulation
- 888.3030
- Classification name
- Software For Diagnosis/Treatment
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Aarno Jussila
- Address
- Htc Helsinki, Bldg. Pinta, Tammasaarenkatu 3 Helsinki Uusimaa FL US 00180 00180
FDA Registration Numbers#
- 1220246
- 1018470
- 3036756245
- 3010363503
- 3038503932
- 3004464325
- 9611863
- 8043792
- 3011302692
- 3006460162
- 2183449
- 3010178296
- 3008812560
- 3021008900
- 1834331
- 9680825
- 3011295718
- 3000270450
- 3008744062
- 3009417901
- 1020279
- 3033509898
- 3010390570
- 3007539489
- 1643264
- 3013510178
- 3002907620
- 1833986
- 1051526
- 1043653
- 3011276773
- 3007366790
- 3009973699
- 9681191
- 3008868758
- 3005497913
- 1526534
- 3034676720
- 3018064242
- 3025603301
- 1833920
Source Documents#
Other 510(k) Records For Product Code OSN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | 2022-08-25 |
| K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | 2018-08-13 |
| K140550 | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | Orthohub, Inc. | 2014-08-25 |