ChanPin MedTak Co., Ltd.

CHANPIN Pedicle Screw Spinal System Receives U.S. FDA 510(k) Clearance

CHANPIN MEDTAK CO., LTD. has long been dedicated to the research, development, and manufacturing of spinal internal fixation systems.

The company’s CHANPIN Pedicle Screw Spinal System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under 510(k) number K251251, with a clearance date of June 9, 2026.

The CHANPIN Pedicle Screw Spinal System is designed to support posterior spinal fixation and is intended for fixation applications involving the thoracic, lumbar, and sacral regions of the spine.

Through the FDA 510(k) review process, the system was determined to be substantially equivalent to a legally marketed predicate device in the United States.

Obtaining U.S. FDA 510(k) clearance represents an important milestone in the company’s continued expansion into international markets.

Looking ahead, CHANPIN will continue to advance the development of spinal surgery products and invest in the innovation of spinal implants and related medical devices. The company remains committed to providing healthcare professionals with a broader range of treatment options and contributing to improved patient care.

FDA 510(k) Number: K251251

FDA Verification: K251251 FDA Database