510(k) K232394
K232394 is an FDA 510(k) premarket notification submitted by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. for the device "Internal Locking Plate and Screw Fixation System". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2023
- Date Received
- August 9, 2023
- 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