Cervical Stand Alone System— 510(k) K161280
Substantially EquivalentOrthofix, Inc.
FDA 510(k) clearance K161280 for Cervical Stand Alone System, Substantially Equivalent on 2016-06-17. Applicant: Orthofix, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthofix, Inc.
- Product code
- Code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lewisville, TX, US
Recent devices under product code OVE
view allMore clearances from Orthofix, Inc.
view all- K240749 — PILLAR SA Ti Spacer System (82-XXX)
- K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
- K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
- K210667 — FIREBIRD SI Fusion System
- K203342 — CONSTRUX Mini Ti Spacer System
Adverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
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.