Clearance Summary
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System received FDA 510(k) clearance under submission number K163383, sponsored by Greens Surgicals Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-04-19.
- Submission: K163383
- Applicant / Sponsor: Greens Surgicals Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-04-19
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.