MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR— 510(k) K844487

Name: FDA 510(k) clearance K844487
Creator: U.S. Food and Drug Administration
Published: 1985-02-19

Substantially Equivalent

Mecron Medical Products, Inc.

FDA 510(k) clearance K844487 for MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR, Substantially Equivalent on 1985-02-19. Applicant: Mecron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mecron Medical Products, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1984-11-19
Decision date: 1985-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWL

view all

K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253675 — OsteoRemedies Hip Spacer System2025-12-23
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

More clearances from Mecron Medical Products, Inc.

view all

K861138 — MASH DERMATOME1986-04-14
K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP1985-11-13
K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE1985-08-12
K844774 — EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS1985-04-22
K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS1985-03-12

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.