PROGENIX PLUS

Bone Grafting Material, Human Source

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Progenix Plus.

Pre-market Notification Details

Device IDK081950
510k NumberK081950
Device Name:PROGENIX PLUS
ClassificationBone Grafting Material, Human Source
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRyan Massey
CorrespondentRyan Massey
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-09
Decision Date2008-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994391049 K081950 000
00613994391032 K081950 000
00613994391025 K081950 000
00613994391018 K081950 000
00763000140571 K081950 000
00763000140564 K081950 000
00763000140557 K081950 000
00763000140540 K081950 000

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