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

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..

Clearance details

Applicant: Acuitive Technologies, Inc.
Product code: Code MAI
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 ↗

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.