ORTHOHELIX STAPLE SYSTEM— 510(k) K142148

Name: FDA 510(k) clearance K142148
Creator: U.S. Food and Drug Administration
Published: 2014-08-21

Substantially Equivalent

Orthohelix Surgical Designs, Inc.

FDA 510(k) clearance K142148 for ORTHOHELIX STAPLE SYSTEM, Substantially Equivalent on 2014-08-21. Applicant: Orthohelix Surgical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Orthohelix Surgical Designs, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2014-08-05
Decision date: 2014-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Medina, OH, US

Download summary PDF View on FDA.gov ↗

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K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES2014-01-03
K132591 — MAXLOCK EXTREME SYSTEM2013-09-17
K130832 — ORTHOHELIX STAPLE SYSTEM2013-08-15

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.