VERTEBRAL SPACER

Spinal Vertebral Body Replacement Device

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Vertebral Spacer.

Pre-market Notification Details

Device IDK011037
510k NumberK011037
Device Name:VERTEBRAL SPACER
ClassificationSpinal Vertebral Body Replacement Device
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-05
Decision Date2002-07-01

NIH GUDID Devices

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