510(k) K230993

CODA™ Anterior Cervical Plate System by Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech — Product Code KWQ

K230993 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech for the device "CODA™ Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on June 20, 2023. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2023
Date Received
April 6, 2023
Clearance Type
Special
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