ASCENSION CANNULATED SCREW SYSTEM— 510(k) K092440

Name: FDA 510(k) clearance K092440
Creator: U.S. Food and Drug Administration
Published: 2009-11-05

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K092440 for ASCENSION CANNULATED SCREW SYSTEM, Substantially Equivalent on 2009-11-05. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2009-08-10
Decision date: 2009-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM2013-02-13
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM2011-12-06
K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.