CODA™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Pioneer Surgical Technology, Inc.,

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc., with the FDA for Coda™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K222493
• 510k Number: K222493
• Device Name: CODA™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Pioneer Surgical Technology, Inc., 375 River Park Circle (DBA Resolve Surgical Technologies) Marquette, MI 49855 -0627
• Contact: Alicia Kaufman
• Correspondent: Alicia Kaufman; Pioneer Surgical Technology, Inc., 375 River Park Circle (DBA Resolve Surgical Technologies) Marquette, MI 49855 -0627
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-18
• Decision Date: 2022-11-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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