TETHER ACFS

Appliance, Fixation, Spinal Intervertebral Body

THEKEN SURGICAL,LLC

The following data is part of a premarket notification filed by Theken Surgical,llc with the FDA for Tether Acfs.

Pre-market Notification Details

• Device ID: K010466
• 510k Number: K010466
• Device Name: TETHER ACFS
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: THEKEN SURGICAL,LLC 1100 NOLA AVE. Barberton, OH 44203
• Contact: Robert Theken
• Correspondent: Robert Theken; THEKEN SURGICAL,LLC 1100 NOLA AVE. Barberton, OH 44203
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-16
• Decision Date: 2001-05-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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