Cleared Traditional

K891472 - IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
(FDA 510(k) Clearance)

K891472 · Implant Technology, Inc. · Orthopedic
May 1989
Decision
48d
Days
Class 2
Risk

K891472 is an FDA 510(k) clearance for the IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR, a System, Cement Removal Extraction (Class II — Special Controls, product code LZV), submitted by Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on May 2, 1989, 48 days after receiving the submission on March 15, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K891472 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1989
Decision Date May 02, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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