SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Anterior Thoracolumbar Rod Clamp (atrc) System.

Pre-market Notification Details

Device IDK974525
510k NumberK974525
Device Name:SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactBarry E Sands
CorrespondentBarry E Sands
SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-02
Decision Date1998-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9814982630 K974525 000
H9814982620 K974525 000
H9814982610 K974525 000
H9814890350 K974525 000

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