THEKEN ATOLL OCT SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Theken Atoll Oct Spinal System.

Pre-market Notification Details

• Device ID: K083863
• 510k Number: K083863
• Device Name: THEKEN ATOLL OCT SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• 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: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-29
• Decision Date: 2009-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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