Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants— 510(k) K221468

Name: FDA 510(k) clearance K221468
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Substantially Equivalent

Acuitive Technologies, Inc.

FDA 510(k) clearance K221468 for Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants, Substantially Equivalent on 2023-02-14. Applicant: Acuitive Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Acuitive Technologies, Inc.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2022-05-20
Decision date: 2023-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alendale, NJ, US

Download summary PDF View on FDA.gov ↗

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K210239 — CITRESPLINE and CITRELOCK ACL Implants2021-02-24
K203334 — The Citrefix Knotless Suture Anchor2021-02-05

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.