DYNESYS TOP-LOADING SPINAL SYSTEM

Posterior Metal/polymer Spinal System, Fusion

ZIMMER SPINE, INC

The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Dynesys Top-loading Spinal System.

Pre-market Notification Details

Device IDK073347
510k NumberK073347
Device Name:DYNESYS TOP-LOADING SPINAL SYSTEM
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2027
ContactElsa A Linke
CorrespondentElsa A Linke
ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2027
Product CodeNQP  
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-29
Decision Date2008-02-08
Summary:summary

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