APEX PINS— 510(k) K061493

Name: FDA 510(k) clearance K061493
Creator: U.S. Food and Drug Administration
Published: 2006-07-07

Substantially Equivalent

Stryker Howmedica Osteonics

FDA 510(k) clearance K061493 for APEX PINS, Substantially Equivalent on 2006-07-07. Applicant: Stryker Howmedica Osteonics. Device class: 2.

Clearance details

Applicant: Stryker Howmedica Osteonics
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2006-05-31
Decision date: 2006-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System2025-10-29
K241357 — XT3 System2025-01-22
K223112 — MAVERICK Mini External Fixation System2022-12-08
K213874 — MAVERICK External Fixation System2022-02-11

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.