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: K101310
• 510k Number: K101310
• Device Name: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: THEKEN SPINE LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Contact: Glenn Stiegman
• Correspondent: Glenn Stiegman; THEKEN SPINE LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-11
• Decision Date: 2010-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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