Acetabular Cup Pusher/Impactor

FDA 510(k) K885305 · Cobot Medical Corp.

Substantially Equivalent

510(k) numberK885305

Submission

Device name
Acetabular Cup Pusher/Impactor
Applicant
Cobot Medical Corp.
Paramus, NJ, US
Received
December 27, 1988
Decision date
February 8, 1989
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
K803165Acetabular Cement CompressorHXO · Traditional Zimmer, Inc.12/31/1980SE
K771072Inserteo, Meta.-Phal.&Thumb Carpo-MetaHXO · Traditional Depuy, Inc.06/27/1977SE

Questions and answers

When was Acetabular Cup Pusher/Impactor cleared by the FDA?

Acetabular Cup Pusher/Impactor (K885305) received a 510(k) decision of Substantially Equivalent on February 8, 1989, 43 days after the submission was received.

What is the product code of K885305?

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