DEPUY ACROMED VBR SYSTEM

Spinal Vertebral Body Replacement Device

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Depuy Acromed Vbr System.

Pre-market Notification Details

• Device ID: K031635
• 510k Number: K031635
• Device Name: DEPUY ACROMED VBR SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: Lisa Gilman
• Correspondent: Lisa Gilman; DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-27
• Decision Date: 2003-06-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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