510(k) K252776

ARIES Anterior Cervical Plate Systems by ZheJiang Decans Medical Devices Co., Ltd. — Product Code KWQ

K252776 is an FDA 510(k) premarket notification submitted by ZheJiang Decans Medical Devices Co., Ltd. for the device "ARIES Anterior Cervical Plate Systems". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. ZheJiang Decans Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type