PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority— 510(k) K152076
Substantially EquivalentStryker
FDA 510(k) clearance K152076 for PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority, Substantially Equivalent on 2015-08-26. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code GWO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portage, MI, US
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Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.