EL CAPITAN Anterior Lumbar Interbody Fusion— 510(k) K222554
Substantially EquivalentAstura Medical
FDA 510(k) clearance K222554 for EL CAPITAN Anterior Lumbar Interbody Fusion, Substantially Equivalent on 2023-01-19. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code OVD
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view all- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K243259 — MASADA Modular Spinal Fixation System
- K240160 — EGPS Navigated Instruments
- K233359 — DOMINION Expandable Corpectomy System
Adverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.