510(k) K201521

Medina Anterior Cervical Plate System by Alliance Partners, LLC — Product Code KWQ

K201521 is an FDA 510(k) premarket notification submitted by Alliance Partners, LLC for the device "Medina Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on August 6, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Alliance Partners, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2020
Date Received
June 8, 2020
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