Fixone Biocomposite Small Anchor— 510(k) K192032

Name: FDA 510(k) clearance K192032
Creator: U.S. Food and Drug Administration
Published: 2020-03-03

Substantially Equivalent

Aju Pharm Co., Ltd.

FDA 510(k) clearance K192032 for Fixone Biocomposite Small Anchor, Substantially Equivalent on 2020-03-03. Applicant: Aju Pharm Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aju Pharm Co., Ltd.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-07-30
Decision date: 2020-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Aju Pharm Co., Ltd.

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K233601 — Fixone Meniscal Repair2024-08-02
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K222423 — Fixone All Suture Anchor2023-03-23
K203523 — Fixone hybrid knotless anchor2021-12-25
K193497 — Fixone Biocomposite Interference Screw2021-01-05

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.