HYBRID ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Hybrid Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K052552
• 510k Number: K052552
• Device Name: HYBRID ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Liz Lavelle
• Correspondent: Liz Lavelle; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-09-16
• Decision Date: 2005-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034134208	K052552	000
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