510(k) K143002
K143002 is an FDA 510(k) premarket notification submitted by Changzhou Dingjian Medical Appliance Co., Ltd. for the device "Metallic Locking Bone Plate and Screw System". The FDA issued a decision of Substantially Equivalent on June 5, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Changzhou Dingjian Medical Appliance Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2015
- Date Received
- October 20, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type