Orthohub External Fixator Software
FDA 510(k) K140550 · Orthohub, Inc.
510(k) numberK140550
Submission
- Device name
- Orthohub External Fixator Software
- Applicant
- Orthohub, Inc.
Menlo Park, CA, US - Received
- March 4, 2014
- Decision date
- August 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSN – Software For Diagnosis/Treatment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Other 510(k)s with product code OSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation SystemOSN · Traditional | Disior, Ltd. | 02/26/2026SE |
| K221792 | Acute QC Strut and ComponentsOSN · Traditional | Smith & Nephew, Inc. | 08/25/2022SE |
| K180539 | Deformity Analysis and Correction Software (DACS) and InstrumentationOSN · Traditional | Arrowhead Medical Device Technologies, LLC | 08/13/2018SE |
Questions and answers
When was Orthohub External Fixator Software cleared by the FDA?
Orthohub External Fixator Software (K140550) received a 510(k) decision of Substantially Equivalent on August 25, 2014, 174 days after the submission was received.
What is the product code of K140550?
The FDA product code is OSN – Software For Diagnosis/Treatment, a Class II (moderate risk) device regulated under 21 CFR 888.3030.