Interpore Cross Cement Restrictor

FDA 510(k) K023908 · Interpore Cross Intl.

Unknown

510(k) numberK023908

Submission

Device name
Interpore Cross Cement Restrictor
Applicant
Interpore Cross Intl.
Irvine, CA, US
Received
November 25, 2002
Decision date
May 16, 2003
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDK – Prosthesis, Hip, Cement Restrictor
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Interpore Cross Cement Restrictor cleared by the FDA?

Interpore Cross Cement Restrictor (K023908) received a 510(k) decision of Unknown on May 16, 2003, 172 days after the submission was received.

What is the product code of K023908?

The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.