DOMINION Expandable Corpectomy System— 510(k) K233359
Substantially EquivalentAstura Medical
FDA 510(k) clearance K233359 for DOMINION Expandable Corpectomy System, Substantially Equivalent on 2024-03-08. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code MQP
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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
- K231694 — MASADA Modular Spinal Fixation System
Adverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
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.