510(k) K123164
K123164 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 15, 2013. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 15, 2013
- Date Received
- Oct 9, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthosis, Spondylolisthesis Spinal Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)