ASCENSION METAL GREAT TOE SYSTEM— 510(k) K092047

Name: FDA 510(k) clearance K092047
Creator: U.S. Food and Drug Administration
Published: 2010-01-14

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K092047 for ASCENSION METAL GREAT TOE SYSTEM, Substantially Equivalent on 2010-01-14. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2009-07-06
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWD

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K221220 — Montross Extremity Medical Hemi Implant System2023-04-19
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25

More clearances from Ascension Orthopedics, Inc.

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K233674 — Freedom Wrist Arthroplasty System2024-05-30
K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
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 KWD

product code KWD

Injury: 164
Total: 164

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.