PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)— 510(k) K143258
Substantially Equivalent4Web, Inc.
FDA 510(k) clearance K143258 for PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), Substantially Equivalent on 2015-04-09. Applicant: 4Web, Inc.. Device class: 2.
Clearance details
- Applicant
- 4Web, Inc.
- Product code
- Code MAX
- 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 MAX
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 MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.