Acetabular Cement Compressor

FDA 510(k) K803165 · Zimmer, Inc.

Substantially Equivalent

510(k) numberK803165

Submission

Device name
Acetabular Cement Compressor
Applicant
Zimmer, Inc.
Mchenry, IL, US
Received
December 15, 1980
Decision date
December 31, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HXO – Pusher, Socket
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HXO

510(k)DeviceApplicantDecision
K885305Acetabular Cup Pusher/ImpactorHXO · Traditional Cobot Medical Corp.02/08/1989SE
K771072Inserteo, Meta.-Phal.&Thumb Carpo-MetaHXO · Traditional Depuy, Inc.06/27/1977SE

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Questions and answers

When was Acetabular Cement Compressor cleared by the FDA?

Acetabular Cement Compressor (K803165) received a 510(k) decision of Substantially Equivalent on December 31, 1980, 16 days after the submission was received.

What is the product code of K803165?

The FDA product code is HXO – Pusher, Socket, a Class I (low risk) device regulated under 21 CFR 888.4540.