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 IDK010466
510k NumberK010466
Device Name:TETHER ACFS
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant THEKEN SURGICAL,LLC 1100 NOLA AVE. Barberton,  OH  44203
ContactRobert Theken
CorrespondentRobert Theken
THEKEN SURGICAL,LLC 1100 NOLA AVE. Barberton,  OH  44203
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-16
Decision Date2001-05-16
Summary:summary

NIH GUDID Devices

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