Cleared Traditional

K803165 - ACETABULAR CEMENT COMPRESSOR (FDA 510(k) Clearance)

K803165 · Zimmer, Inc. · Orthopedic device

Dec 1980

Decision

16d

Days

Class 1

Risk

K803165 is an FDA 510(k) clearance for the ACETABULAR CEMENT COMPRESSOR. This device is classified as a Pusher, Socket (Class I - General Controls, product code HXO).

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 16 days after receiving the submission on December 15, 1980.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K803165 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 15, 1980
Decision Date	December 31, 1980
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HXO — Pusher, Socket
Device Class	Class I - General Controls
CFR Regulation	21 CFR 888.4540