TOTAL SPINAL CORRECTION

Implant, Fixation Device, Spinal

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Total Spinal Correction.

Pre-market Notification Details

Device IDK760649
510k NumberK760649
Device Name:TOTAL SPINAL CORRECTION
ClassificationImplant, Fixation Device, Spinal
Applicant DEPUY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJDN  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-09-15
Decision Date1976-10-05

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