AUTODYNAMIC COMPRESSION HIP SCREW-PLATE— 510(k) K843449

Name: FDA 510(k) clearance K843449
Creator: U.S. Food and Drug Administration
Published: 1984-10-22

Substantially Equivalent

Mecron Medical Products, Inc.

FDA 510(k) clearance K843449 for AUTODYNAMIC COMPRESSION HIP SCREW-PLATE, Substantially Equivalent on 1984-10-22. Applicant: Mecron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mecron Medical Products, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1984-09-05
Decision date: 1984-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Washington, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTT

view all

K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
K260900 — DYNEX® External Fixation Systems2026-04-17
K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

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 KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.