OSTEOTRANS-OT PIN— 510(k) K073311

Name: FDA 510(k) clearance K073311
Creator: U.S. Food and Drug Administration
Published: 2008-05-13

Substantially Equivalent

Takiron Co., Ltd.

FDA 510(k) clearance K073311 for OSTEOTRANS-OT PIN, Substantially Equivalent on 2008-05-13. Applicant: Takiron Co., Ltd.. Device class: 2.

Clearance details

Applicant: Takiron Co., Ltd.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2007-11-23
Decision date: 2008-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, Kobe, Hyogo, JP

Download summary PDF View on FDA.gov ↗

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K062691 — COMPORUS2008-04-15
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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.