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FDA 510(k) Applications for Medical Device Product Code "HBW"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K001353 | BIOMEDICAL ENT., INC. | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | 03/13/2001 |
K141385 | DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | 03/27/2015 |
K101835 | POREX SURGICAL, INC. | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | 12/03/2010 |
K171152 | Stryker | Stryker Universal Neuro III System AXS Screw | 05/19/2017 |
K151387 | STRYKER | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | 06/24/2015 |
K231208 | Stryker Leibinger GmbH & Co. KG | Stryker Resorbable Fixation System | 08/14/2023 |