MODIFICATION TO TSRH SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Tsrh Spinal System.

Pre-market Notification Details

Device IDK011067
510k NumberK011067
Device Name:MODIFICATION TO TSRH SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-09
Decision Date2001-05-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902066399 K011067 000
00721902066009 K011067 000
00721902066016 K011067 000
00721902066023 K011067 000
00721902066030 K011067 000
00721902066061 K011067 000
00721902066078 K011067 000
00721902066085 K011067 000
00721902066092 K011067 000
00721902066108 K011067 000
00721902066115 K011067 000
00721902066122 K011067 000
00721902066139 K011067 000
00721902066146 K011067 000
00721902066160 K011067 000
00721902066177 K011067 000
00721902066375 K011067 000
00721902066382 K011067 000
00721902065996 K011067 000

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