Product code HBW
- Device name
- Fastener, Plate, Cranioplasty
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5360
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY | 2025-07-11 |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017-05-19 |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker | 2015-06-24 |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | 2010-12-03 |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | 2001-03-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327177534 | DELTA | Stryker Leibinger GmbH & Co. KG | 2018-04-16 |
| 07613327177541 | DELTA | Stryker Leibinger GmbH & Co. KG | 2017-03-09 |
| 07613327177510 | DELTA | Stryker Leibinger GmbH & Co. KG | 2017-03-09 |
| 07613252528999 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327090185 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327090147 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252727842 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252727835 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252727002 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252713128 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252616115 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252616108 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252600176 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252600169 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252529002 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613153066828 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252477464 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252467519 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252448808 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444244 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252444213 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252313083 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252313076 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252313069 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252270768 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252009597 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613252009580 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613154991143 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613154629077 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613153066842 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |