FIXIT / ComposiTCP Threaded Anchor System— 510(k) K180960

Name: FDA 510(k) clearance K180960
Creator: U.S. Food and Drug Administration
Published: 2018-07-25

Substantially Equivalent

S.B.M. Sas Sciences For Bio Materials

FDA 510(k) clearance K180960 for FIXIT / ComposiTCP Threaded Anchor System, Substantially Equivalent on 2018-07-25. Applicant: S.B.M. Sas Sciences For Bio Materials. Device class: 2.

Clearance details

Applicant: S.B.M. Sas Sciences For Bio Materials
Product code: Product code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-04-12
Decision date: 2018-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Lourdes, FR

Download summary PDF View on FDA.gov ↗

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K254055 — OSSIOfiber® Suture Anchor2026-02-24
K251680 — Biosteon® Screw2026-02-17

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.