ZION Anterior Cervical Fixation System— 510(k) K160702
Substantially EquivalentAstura Medical
FDA 510(k) clearance K160702 for ZION Anterior Cervical Fixation System, Substantially Equivalent on 2016-08-23. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code KWQ
view allMore clearances from Astura Medical
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 KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.