GRAFTCAGE TLX

Spinal Vertebral Body Replacement Device

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Graftcage Tlx.

Pre-market Notification Details

Device IDK051781
510k NumberK051781
Device Name:GRAFTCAGE TLX
ClassificationSpinal Vertebral Body Replacement Device
Applicant OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
ContactChristopher Talbot
CorrespondentChristopher Talbot
OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-01
Decision Date2005-12-16
Summary:summary

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