FDA 510(k)

PCA TOTAL HIP SYSTEM (CEMENTLESS USE)

K-Number: K920831 · 1992-06-10

ApplicantPfizer Hospital Products Group, Inc.

Decision Date1992-06-10

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PCA TOTAL HIP SYSTEM (CEMENTLESS USE) is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Hospital Products Group, Inc.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K920831. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCA TOTAL HIP SYSTEM (CEMENTLESS USE)?

PCA TOTAL HIP SYSTEM (CEMENTLESS USE) is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Pfizer Hospital Products Group, Inc.. The 510(k) number is K920831.

When did PCA TOTAL HIP SYSTEM (CEMENTLESS USE) receive FDA 510(k) clearance?

PCA TOTAL HIP SYSTEM (CEMENTLESS USE) received FDA 510(k) clearance on 1992-06-10, under 510(k) number K920831.

Who is the listed applicant for PCA TOTAL HIP SYSTEM (CEMENTLESS USE)?

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

What is the FDA product code for PCA TOTAL HIP SYSTEM (CEMENTLESS USE)?

The FDA product code for PCA TOTAL HIP SYSTEM (CEMENTLESS USE) is LPH.

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Other records listing Pfizer Hospital Products Group, Inc. as applicant

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Related Devices (Code: LPH)

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Official Source

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