Eminent Spine Scoliosis Deformity Pedicle Screw System— 510(k) K242069
Substantially EquivalentEminent Spine
FDA 510(k) clearance K242069 for Eminent Spine Scoliosis Deformity Pedicle Screw System, Substantially Equivalent on 2024-09-03. Applicant: Eminent Spine. Device class: 2.
Clearance details
- Applicant
- Eminent Spine
- 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
- Special
- Location
- Plano, TX, US
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More clearances from Eminent Spine
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.