K232394
- 510(k) number
- K232394
- Device name
- Internal Locking Plate and Screw Fixation System
- Applicant
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. CN
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-12-15
- Date received
- 2023-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232394.pdf
Official FDA record: K232394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.