TRUE/FLEX METATARSAL RODS— 510(k) K924657

Name: FDA 510(k) clearance K924657
Creator: U.S. Food and Drug Administration
Published: 1992-11-24

Substantially Equivalent

Applied Osteo Systems, Inc.

FDA 510(k) clearance K924657 for TRUE/FLEX METATARSAL RODS, Substantially Equivalent on 1992-11-24. Applicant: Applied Osteo Systems, Inc.. Device class: 2.

Clearance details

Applicant: Applied Osteo Systems, Inc.
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1992-09-15
Decision date: 1992-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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K944501 — TRUE/FLEX INTRAMEDULLARY ROD END-CAP1994-11-28
K941048 — TRUE/LOK MONOLATERAL/BILATERAL FIXATOR1994-10-03
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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.