510(k) K160003
K160003 is an FDA 510(k) premarket notification submitted by Spine Wave, Inc. for the device "Sniper (R) Spine System". The FDA issued a decision of Substantially Equivalent on February 26, 2016. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spine Wave, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2016
- Date Received
- January 4, 2016
- 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