DSC/ALF SPINAL SYSTEM— 510(k) K101886

Name: FDA 510(k) clearance K101886
Creator: U.S. Food and Drug Administration
Published: 2011-07-21

Substantially Equivalent

Sintea Plastek, LLC

FDA 510(k) clearance K101886 for DSC/ALF SPINAL SYSTEM, Substantially Equivalent on 2011-07-21. Applicant: Sintea Plastek, LLC. Device class: 2.

Clearance details

Applicant: Sintea Plastek, LLC
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2010-07-06
Decision date: 2011-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

view all

K261810 — Vertiwedge® Intraosseous System2026-07-31
K261031 — POSEIDON ST2026-07-10
K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Sintea Plastek, LLC

view all

K112611 — SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS2012-04-25

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.