CPS, Cemented Hip System

FDA 510(k) K961899 · Artos Medical Products GmbH

Substantially Equivalent

510(k) numberK961899

Submission

Device name
CPS, Cemented Hip System
Applicant
Artos Medical Products GmbH
Indianapolis, IN, US
Received
May 16, 1996
Decision date
August 1, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3350
Specialty
Orthopedic
Implant
Yes

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K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional Howmedica Osteonics Corp., Dba Stryker…08/02/2024SE
K240418Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional Howmedica Osteonics Corp., Dba Stryker…04/12/2024SE
K233261Global Modular Replacement SystemJDI · Traditional Howmedica Osteonics Corp. A.K.A. Stryker…12/08/2023SE
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional Howmedica Osteonics Corp., Dba Stryker…01/26/2023SE
K220216C-Stem AMT LE ProsthesisJDI · Traditional Depuy Ireland UC07/22/2022SE

More from Depuy Ireland UC

510(k)DeviceDecision
K962268Chrome Cobalt Ball HeadLWJ · Traditional 10/23/1996SE
K962034SC, Cementless Hip SystemLWJ · Traditional 10/23/1996SE
K962086CPS, Cemented Cup SystemJDI · Traditional 08/07/1996SE

Questions and answers

When was CPS, Cemented Hip System cleared by the FDA?

CPS, Cemented Hip System (K961899) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 77 days after the submission was received.

What is the product code of K961899?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.