THEKEN ATOLL CERVICO-THORACIC SYSTEM

Appliance, Fixation, Spinal Interlaminal

THEKEN SPINE LLC

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

Pre-market Notification Details

• Device ID: K070638
• 510k Number: K070638
• Device Name: THEKEN ATOLL CERVICO-THORACIC SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• 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: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-07
• Decision Date: 2007-05-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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