OIC Intramedullary Screw System— 510(k) K223761

Name: FDA 510(k) clearance K223761
Creator: U.S. Food and Drug Administration
Published: 2023-02-13

Substantially Equivalent

Orthopaedic Implant Company

FDA 510(k) clearance K223761 for OIC Intramedullary Screw System, Substantially Equivalent on 2023-02-13. Applicant: Orthopaedic Implant Company. Device class: 2.

Clearance details

Applicant: Orthopaedic Implant Company
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2022-12-15
Decision date: 2023-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K261057 — ActivaScrew Cannulated COM2026-09-04
K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

More clearances from Orthopaedic Implant Company

view all

K233531 — OIC FLEX-FIX System2024-02-02
K223118 — OIC Variable Angle Small Fragment Locking Plate System2023-01-21
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 HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.