Cervical Spinal Truss System (CSTS) Interbody Fusion Device— 510(k) K173159
Substantially Equivalent4Web, Inc.
FDA 510(k) clearance K173159 for Cervical Spinal Truss System (CSTS) Interbody Fusion Device, Substantially Equivalent on 2018-01-08. Applicant: 4Web, Inc.. Device class: 2.
Clearance details
- Applicant
- 4Web, Inc.
- Product code
- Code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frisco, TX, US
Recent devices under product code ODP
view allMore clearances from 4Web, Inc.
view all- K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS)
- K203065 — Lumbar Spine Truss System Plating Solution (LSTS-PS)
- K200002 — Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
- K190870 — Cervical Spinal Truss System-Stand Alone (CSTS-SA)
- K190926 — Hammertoe Truss System (HTS)
Adverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
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.