DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE— 510(k) K945294

Name: FDA 510(k) clearance K945294
Creator: U.S. Food and Drug Administration
Published: 1995-03-07

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K945294 for DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE, Substantially Equivalent for Some Indications on 1995-03-07. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1994-10-31
Decision date: 1995-03-07
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 JDQ

view all

K261271 — Cable-Ready® Cable Grip System2026-07-16
K243905 — Stitch Cerclage Suture Tapes2025-08-14
K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures2025-02-20
K232733 — Mbrace Cable2024-05-03
K233949 — ACCORD Cable System2024-03-13

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 JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.