QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments— 510(k) K161591
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K161591 for QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Substantially Equivalent on 2016-09-21. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code NKG
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Adverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
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.