CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System— 510(k) K190385

Name: FDA 510(k) clearance K190385
Creator: U.S. Food and Drug Administration
Published: 2019-08-08

Substantially Equivalent

In2bones USA, LLC

FDA 510(k) clearance K190385 for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System, Substantially Equivalent on 2019-08-08. Applicant: In2bones USA, LLC. Device class: 2.

Clearance details

Applicant: In2bones USA, LLC
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-02-19
Decision date: 2019-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K261511 — Xpert Ankle2026-07-28

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K261154 — CoLink® & CoLag® Non-Sterile Screws2026-05-30
K233089 — NeoSpan® Compression Implant System2024-05-24
K231236 — IBS-B MIS Beveled Screw System2023-07-27
K213698 — CoLink PCR Plating System2022-05-27
K220260 — Hercules Syndesmosis Implant System2022-03-31

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.