Cleared Traditional

STRYKER 2115 REPLACEMENT BATTERY (2115)

K970378 · Implant Resource, Inc. · Orthopedic

Apr 1997

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K970378 is an FDA 510(k) clearance for the STRYKER 2115 REPLACEMENT BATTERY (2115), a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I — General Controls, product code KIJ), submitted by Implant Resource, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 1997, 89 days after receiving the submission on January 31, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K970378 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 1997
Decision Date	April 30, 1997
Days to Decision	89 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