Cleared Traditional

SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY

K951450 · Strenumed, Inc. · Orthopedic

May 1995

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K951450 is an FDA 510(k) clearance for the SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY, a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I — General Controls, product code KIJ), submitted by Strenumed, Inc. (Ventura, US). The FDA issued a Cleared decision on May 17, 1995, 49 days after receiving the submission on March 29, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K951450 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 1995
Decision Date	May 17, 1995
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820