CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

CHOICE SPINE, LP

The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Choice Spine Anterior Cervical Plate (acp) System.

Pre-market Notification Details

• Device ID: K091926
• 510k Number: K091926
• Device Name: CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141
• Contact: Karen Warden
• Correspondent: Karen Warden; CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-30
• Decision Date: 2009-12-22
• Summary: summary

NIH GUDID Devices

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