OIC FLEX-FIX System— 510(k) K233531

Name: FDA 510(k) clearance K233531
Creator: U.S. Food and Drug Administration
Published: 2024-02-02

Substantially Equivalent

Orthopaedic Implant Company

FDA 510(k) clearance K233531 for OIC FLEX-FIX System, Substantially Equivalent on 2024-02-02. Applicant: Orthopaedic Implant Company. Device class: 2.

Clearance details

Applicant: Orthopaedic Implant Company
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-11-02
Decision date: 2024-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Orthopaedic Implant Company

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K223761 — OIC Intramedullary Screw System2023-02-13
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K212601 — DRPx Locking Distal Radius Plate System2022-04-05
K202971 — DRPx Locking Distal Radius Plate System2021-05-06
K211112 — OIC External Fixation System2021-05-05

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.