VU APOD INTERVERTEBRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Integrated Fixation, Lumbar

THEKEN SPINE, LLC

The following data is part of a premarket notification filed by Theken Spine, Llc with the FDA for Vu Apod Intervertebral Body Fusion Device.

Pre-market Notification Details

• Device ID: K121211
• 510k Number: K121211
• Device Name: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: THEKEN SPINE, LLC 1153 Medina Rd. Medina, OH 44256
• Contact: Dale Davison
• Correspondent: Dale Davison; THEKEN SPINE, LLC 1153 Medina Rd. Medina, OH 44256
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-20
• Decision Date: 2012-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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