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510(k) K141385

Device
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
Applicant
DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON
510(k) number
K141385
Product code
HBW  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-27
Date received
2014-05-27
Regulation
882.5360
Classification name
Fastener, Plate, Cranioplasty
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY DOW
Address
1230 Wilson Dr. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY2025-07-11
K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG2023-08-14
K171152Stryker Universal Neuro III System AXS ScrewStryker2017-05-19
K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker2015-06-24
K101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079Porex Surgical, Inc.2010-12-03
K001353MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEMBiomedical Ent., Inc.2001-03-13

Legacy Summary#

summary

FDA Review#

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