INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY

Arthroscope

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Instrument System For Endoscopic Spinal Surgery.

Pre-market Notification Details

Device IDK121482
510k NumberK121482
Device Name:INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
ClassificationArthroscope
Applicant THEKEN SPINE LLC 1153 MEDINA RD. Medina,  OH  44256 -0000
ContactDale Davison
CorrespondentDale Davison
THEKEN SPINE LLC 1153 MEDINA RD. Medina,  OH  44256 -0000
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-18
Decision Date2012-08-28
Summary:summary

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