N-FORCE FIXATION SYSTEM— 510(k) K102528

Name: FDA 510(k) clearance K102528
Creator: U.S. Food and Drug Administration
Published: 2011-07-28

Substantially Equivalent

Innovision, Inc.

FDA 510(k) clearance K102528 for N-FORCE FIXATION SYSTEM, Substantially Equivalent on 2011-07-28. Applicant: Innovision, Inc.. Device class: 2.

Clearance details

Applicant: Innovision, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2010-09-03
Decision date: 2011-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

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

More clearances from Innovision, Inc.

view all

K151146 — N-Force Fixation System2015-07-24
K132244 — N-FORCE FIXATION SYSTEM2014-03-06
K011914 — HYDRO2, HS-752001-07-27
K000485 — HYDRO2, HS-752000-05-12
K944223 — ACCUCON1994-12-07

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.