510(k) K190842
K190842 is an FDA 510(k) premarket notification submitted by Jiangsu Trauhui Medical Instrument Co., Ltd. for the device "Comus Locking Plate systems". The FDA issued a decision of Substantially Equivalent on Feb 3, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Jiangsu Trauhui Medical Instrument Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2020
- Date Received
- Apr 1, 2019
- 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
- 510(k)