510(k) K143222
K143222 is an FDA 510(k) premarket notification submitted by Mighty Oak Medical, Inc. for the device "FIREFLY Pedicle Screw Navigation Guide". The FDA issued a decision of Substantially Equivalent on December 11, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Mighty Oak Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2015
- Date Received
- November 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type