510(k) K140550
- Device
- ORTHOHUB EXTERNAL FIXATOR SOFTWARE
- Applicant
- ORTHOHUB, INC.
- 510(k) number
- K140550
- Product code
- OSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-25
- Date received
- 2014-03-04
- 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
- No
Applicant Contact#
- Contact
- PEGGY MCLAUGHLIN
- Address
- 999 Menlo Oaks Dr. Menlo Park CA US 94025 94025
FDA Registration Numbers#
- 8043792
- 3013510178
- 3000270450
- 3007366790
- 3011302692
- 1220246
- 3038503932
- 3010390570
- 3018064242
- 9680825
- 3007539489
- 3021008900
- 1833986
- 3004464325
- 3002907620
- 3011295718
- 9611863
- 1020279
- 1051526
- 3009973699
- 3034676720
- 2183449
- 3008868758
- 3010363503
- 3011276773
- 1018470
- 3009417901
- 1833920
- 1834331
- 3006460162
- 3008812560
- 3036756245
- 1043653
- 1526534
- 3005497913
- 3010178296
- 3025603301
- 1643264
- 3033509898
- 9681191
- 3008744062
Source Documents#
Other 510(k) Records For Product Code OSN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026-02-26 |
| 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 |
Legacy Summary#
summary
FDA Review#
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