Cleared Traditional

STRYKER CEMENT REMOVAL SYSTEM

K961101 · Stryker Corp. · Orthopedic
Jul 1996
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K961101 is an FDA 510(k) clearance for the STRYKER CEMENT REMOVAL SYSTEM, a System, Cement Removal Extraction (Class II — Special Controls, product code LZV), submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on July 15, 1996, 118 days after receiving the submission on March 19, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K961101 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1996
Decision Date July 15, 1996
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZV — System, Cement Removal Extraction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.4580

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