INZONE DETACHMENT SYSTEM— 510(k) K120816
Substantially EquivalentStryker
FDA 510(k) clearance K120816 for INZONE DETACHMENT SYSTEM, Substantially Equivalent on 2012-04-17. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fremont, CA, US
Recent devices under product code KRD
view allMore clearances from Stryker
view all- K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- 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 KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
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.