VU E*POD VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Vu E*pod Vertebral Body Replacement.

Pre-market Notification Details

• Device ID: K071031
• 510k Number: K071031
• Device Name: VU E*POD VERTEBRAL BODY REPLACEMENT
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319
• Contact: Dale Davison
• Correspondent: Dale Davison; THEKEN SPINE LLC 283 E WATERLOO RD. Akron, OH 44319
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-11
• Decision Date: 2007-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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