Cleared Traditional

INTRAMEDULLARY HIP SCREW

K895241 · Richards Medical Co., Inc. · Orthopedic

Jan 1990

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K895241 is an FDA 510(k) clearance for the INTRAMEDULLARY HIP SCREW, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on January 4, 1990, 136 days after receiving the submission on August 21, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K895241 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1989
Decision Date	January 04, 1990
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030