OS2-C Compression Staple— 510(k) K153395

Name: FDA 510(k) clearance K153395
Creator: U.S. Food and Drug Administration
Published: 2016-02-18

Substantially Equivalent

In2bones Sas

FDA 510(k) clearance K153395 for OS2-C Compression Staple, Substantially Equivalent on 2016-02-18. Applicant: In2bones Sas. Device class: 2.

Clearance details

Applicant: In2bones Sas
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2015-11-24
Decision date: 2016-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ecully, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.