TETRIS SPINAL IMPLANT— 510(k) K022793

Name: FDA 510(k) clearance K022793
Creator: U.S. Food and Drug Administration
Published: 2003-04-08

Substantially Equivalent

Signus Medical, LLC

FDA 510(k) clearance K022793 for TETRIS SPINAL IMPLANT, Substantially Equivalent on 2003-04-08. Applicant: Signus Medical, LLC. Device class: 2.

Clearance details

Applicant: Signus Medical, LLC
Product code: Product code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2002-08-23
Decision date: 2003-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Signus Medical, LLC

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K081108 — MONOPOLY PEDICLE SCREW SYSTEM2008-07-14
K052096 — NUBIC SPINAL IMPLANT2005-08-16
K031455 — CONKLUSION PEDICLE SCREW SYSTEM2003-10-22
K031757 — PEEK TETRIS SPINAL IMPLANT2003-07-30
K020836 — RABEA CEMENT RESTRICTOR2002-06-11

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.