SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Universal Spine Rod And Screw Fixation Sys.

Pre-market Notification Details

Device IDK922855
510k NumberK922855
Device Name:SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactDiane C Tiernan
CorrespondentDiane C Tiernan
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-15
Decision Date1993-06-24

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