Geo Staple System— 510(k) K182212

Name: FDA 510(k) clearance K182212
Creator: U.S. Food and Drug Administration
Published: 2019-01-11

Substantially Equivalent

Gramercy Extremity Orthopedics, LLC

FDA 510(k) clearance K182212 for Geo Staple System, Substantially Equivalent on 2019-01-11. Applicant: Gramercy Extremity Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: Gramercy Extremity Orthopedics, LLC
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-08-15
Decision date: 2019-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

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K202817 — GEO Bone Screw System2020-10-22
K200108 — GEO 1st MTP Joint Arthrodesis Plating System2020-03-26

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.