Golden Isles Pedicle Screw System— 510(k) K212185
Substantially EquivalentIntelivation, LLC
FDA 510(k) clearance K212185 for Golden Isles Pedicle Screw System, Substantially Equivalent on 2021-08-19. Applicant: Intelivation, LLC. Device class: 2.
Clearance details
- Applicant
- Intelivation, LLC
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Simons Island, GA, US
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- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
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More clearances from Intelivation, LLC
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.