FDA 510(k)

PBP TOTAL HIP SYSTEM

K-Number: K122158 · 2012-12-11

ApplicantPipeline Biomedical Products, LLC

Decision Date2012-12-11

Product CodeOQG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PBP TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Biomedical Products, LLC. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K122158. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PBP TOTAL HIP SYSTEM?

PBP TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Pipeline Biomedical Products, LLC. The 510(k) number is K122158.

When did PBP TOTAL HIP SYSTEM receive FDA 510(k) clearance?

PBP TOTAL HIP SYSTEM received FDA 510(k) clearance on 2012-12-11, under 510(k) number K122158.

Who is the listed applicant for PBP TOTAL HIP SYSTEM?

The FDA 510(k) record lists Pipeline Biomedical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PBP TOTAL HIP SYSTEM?

The FDA product code for PBP TOTAL HIP SYSTEM is OQG.

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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.