DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Mesh, Surgical

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Restore Orthobiologic Soft Tissue Implant.

Pre-market Notification Details

Device IDK031969
510k NumberK031969
Device Name:DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
ClassificationMesh, Surgical
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactKathy K Trier
CorrespondentKathy K Trier
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-07-28
Summary:summary

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