510(k) K160320
K160320 is an FDA 510(k) premarket notification submitted by Shandong Weigao Orthopaedic Device Co., Ltd. for the device "Premier". The FDA issued a decision of Substantially Equivalent on April 1, 2016. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Shandong Weigao Orthopaedic Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2016
- Date Received
- February 5, 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