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510(k) K141385

DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) by Depuy Synthes Companies of Johnson & Johnson — Product Code HBW

K141385 is an FDA 510(k) premarket notification submitted by Depuy Synthes Companies of Johnson & Johnson for the device "DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)". The FDA issued a decision of Substantially Equivalent on March 27, 2015. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2015
Date Received
May 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
Submission Type

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FDA data resources