PEEK CUSTOMIZED CRAIAL IMPLANT KIT— 510(k) K121153
Substantially EquivalentStryker
FDA 510(k) clearance K121153 for PEEK CUSTOMIZED CRAIAL IMPLANT KIT, Substantially Equivalent on 2012-09-14. 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
- Traditional
- Location
- Portage, MI, US
Recent devices under product code GWO
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- K230754 — L12 LED Light Source with AIM
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
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.