FDA 510(k)

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00

K-Number: K030265 · 2003-03-04

Decision Date2003-03-04

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2003-03-04 under 510(k) number K030265. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00?

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 is a medical device that received FDA 510(k) clearance on 2003-03-04. The listed applicant is Zimmer, Inc.. The 510(k) number is K030265.

When did CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 receive FDA 510(k) clearance?

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 received FDA 510(k) clearance on 2003-03-04, under 510(k) number K030265.

Who is the listed applicant for CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00?

The FDA product code for CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 is JDI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.