CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Integrated Fixation, Cervical

THEKEN SPINE LLC

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

Pre-market Notification Details

• Device ID: K102323
• 510k Number: K102323
• Device Name: CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306
• Contact: Dale Davison
• Correspondent: Dale Davison; THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-17
• Decision Date: 2010-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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