GEO Bone Screw System— 510(k) K161904

Name: FDA 510(k) clearance K161904
Creator: U.S. Food and Drug Administration
Published: 2017-01-18

Substantially Equivalent

Gramercy Extremity Orthopeidics, LLC

FDA 510(k) clearance K161904 for GEO Bone Screw System, Substantially Equivalent on 2017-01-18. Applicant: Gramercy Extremity Orthopeidics, LLC. Device class: 2.

Clearance details

Applicant: Gramercy Extremity Orthopeidics, LLC
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2016-07-11
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

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K261057 — ActivaScrew Cannulated COM2026-09-04
K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.