STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW— 510(k) K953369

Name: FDA 510(k) clearance K953369
Creator: U.S. Food and Drug Administration
Published: 1995-09-08

Substantially Equivalent for Some Indications

Advanced Spine Fixation Systems, Inc.

FDA 510(k) clearance K953369 for STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW, Substantially Equivalent for Some Indications on 1995-09-08. Applicant: Advanced Spine Fixation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Spine Fixation Systems, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1995-07-18
Decision date: 1995-09-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.