Stealth Staple System— 510(k) K163440

Name: FDA 510(k) clearance K163440
Creator: U.S. Food and Drug Administration
Published: 2017-02-01

Substantially Equivalent

First Ray, LLC

FDA 510(k) clearance K163440 for Stealth Staple System, Substantially Equivalent on 2017-02-01. Applicant: First Ray, LLC. Device class: 2.

Clearance details

Applicant: First Ray, LLC
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2016-12-08
Decision date: 2017-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

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K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

More clearances from First Ray, LLC

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K153585 — Flip Button Suture Anchor2016-05-05
K153638 — Bicortical Fixation Screw & Washer Nut System2016-04-19
K153622 — First Ray Internal Bone Staple System2016-04-08

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.