MALLORY/HEAD TOTAL HIP SYSTEM— 510(k) K853259

Name: FDA 510(k) clearance K853259
Creator: U.S. Food and Drug Administration
Published: 1985-11-01

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K853259 for MALLORY/HEAD TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1985-11-01. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KMC
Device class: Class 2
Regulation: 21 CFR 888.3340
Advisory panel: Orthopedic
Date received: 1985-08-02
Decision date: 1985-11-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMC

view all

K936044 — ENHANCED MODULAR AUSTIN MOORE HIP1994-04-26
K853524 — APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT1985-11-22

More clearances from Biomet, Inc.

view all

K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.