510(k) K171082
K171082 is an FDA 510(k) premarket notification submitted by Orthofix, Inc. for the device "Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on May 5, 2017. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Orthofix, Inc. has 97 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2017
- Date Received
- Apr 11, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.