ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM— 510(k) K001044

Name: FDA 510(k) clearance K001044
Creator: U.S. Food and Drug Administration
Published: 2000-11-03

Substantially Equivalent for Some Indications

Acme Spine, LLC

FDA 510(k) clearance K001044 for ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM, Substantially Equivalent for Some Indications on 2000-11-03. Applicant: Acme Spine, LLC. Device class: 2.

Clearance details

Applicant: Acme Spine, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2000-03-31
Decision date: 2000-11-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Riverside, 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.