510(k) K143013
K143013 is an FDA 510(k) premarket notification submitted by Changzhou Dingjian Medical Appliance Co., Ltd. for the device "Spinal Inner Fixation System". The FDA issued a decision of Substantially Equivalent on December 11, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Changzhou Dingjian Medical Appliance Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2015
- Date Received
- October 20, 2014
- 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