6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW— 510(k) K944213

Name: FDA 510(k) clearance K944213
Creator: U.S. Food and Drug Administration
Published: 1994-12-09

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K944213 for 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW, Substantially Equivalent for Some Indications on 1994-12-09. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1994-08-29
Decision date: 1994-12-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, 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 Howmedica Corp.

view all

K983528 — MICRO DYNAMIC MESH1998-12-23
K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

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.