Cleared Traditional

DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)

K141385 · Depuy Synthes Companies of Johnson & Johnson · Neurology

Mar 2015

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K141385 is an FDA 510(k) clearance for the DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS), a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Depuy Synthes Companies of Johnson & Johnson (West Chester, US). The FDA issued a Cleared decision on March 27, 2015, 304 days after receiving the submission on May 27, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.

Submission Details

510(k) Number	K141385 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2014
Decision Date	March 27, 2015
Days to Decision	304 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF