ACCIN PEDICLE SCREW SYSTEM— 510(k) K073531

Name: FDA 510(k) clearance K073531
Creator: U.S. Food and Drug Administration
Published: 2008-02-04

Substantially Equivalent

Accelerated Innovation, LLC

FDA 510(k) clearance K073531 for ACCIN PEDICLE SCREW SYSTEM, Substantially Equivalent on 2008-02-04. Applicant: Accelerated Innovation, LLC. Device class: 2.

Clearance details

Applicant: Accelerated Innovation, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2007-12-17
Decision date: 2008-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, US

Download summary PDF View on FDA.gov ↗

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K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Accelerated Innovation, LLC

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K081127 — ACCIN TOTAL KNEE SYSTEM2008-10-17
K080647 — ACCIN BIPOLAR HEAD SYSTEM2008-07-08
K080539 — ACCIN UNIPOLAR HEAD SYSTEM2008-06-02
K073120 — ACCIN PATELLOFEMORAL SYSTEM2008-02-29
K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM2008-01-31

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.