510(k) K140550
K140550 is an FDA 510(k) premarket notification submitted by Orthohub, Inc. for the device "ORTHOHUB EXTERNAL FIXATOR SOFTWARE". The FDA issued a decision of Substantially Equivalent on Aug 25, 2014. The device falls under product code OSN (Software For Diagnosis/Treatment), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 25, 2014
- Date Received
- Mar 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software For Diagnosis/Treatment
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions