VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Vertebral Body Replacement.

Pre-market Notification Details

Device IDK003155
510k NumberK003155
Device Name:VERTEBRAL BODY REPLACEMENT
ClassificationSpinal Vertebral Body Replacement Device
Applicant OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
ContactKim Thurman
CorrespondentKim Thurman
OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-10
Decision Date2001-01-04

NIH GUDID Devices

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