DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)

Fastener, Plate, Cranioplasty

DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON

The following data is part of a premarket notification filed by Depuy Synthes Companies Of Johnson & Johnson with the FDA for Depuy Synthes Injectable Polymer System (ips).

Pre-market Notification Details

Device IDK141385
510k NumberK141385
Device Name:DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
ClassificationFastener, Plate, Cranioplasty
Applicant DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON 1230 WILSON DRIVE West Chester,  PA  19380
ContactJeffrey Dow
CorrespondentJeffrey Dow
DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON 1230 WILSON DRIVE West Chester,  PA  19380
Product CodeHBW  
CFR Regulation Number882.5360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2015-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98053055501S0 K141385 000
H98080555001S0 K141385 000
H98080552001S0 K141385 000
H98080551001S0 K141385 000
H98080550501S0 K141385 000
H9805305540 K141385 000
H98053055301S0 K141385 000
H9805305510 K141385 000

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