TRABECULAR METAL (TM) FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Cervical

ZIMMER SPINE, INC

The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Trabecular Metal (tm) Fusion Device.

Pre-market Notification Details

Device IDK111119
510k NumberK111119
Device Name:TRABECULAR METAL (TM) FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant ZIMMER SPINE, INC 12708 RIATA VISTA CIRCLE SUITE B-100 Austin,  TX  78727
ContactJennifer Tribbett
CorrespondentJennifer Tribbett
ZIMMER SPINE, INC 12708 RIATA VISTA CIRCLE SUITE B-100 Austin,  TX  78727
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-21
Decision Date2011-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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