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FDA 510(k)

U1 HIP SYSTEM - BIPOLAR

K-Number: K050269 · 2005-08-29

ApplicantUnited Orthopedic Corp.
Decision Date2005-08-29
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U1 HIP SYSTEM - BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corp.. It received FDA 510(k) clearance on 2005-08-29 under 510(k) number K050269. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U1 HIP SYSTEM - BIPOLAR?

U1 HIP SYSTEM - BIPOLAR is a medical device that received FDA 510(k) clearance on 2005-08-29. The listed applicant is United Orthopedic Corp.. The 510(k) number is K050269.

When did U1 HIP SYSTEM - BIPOLAR receive FDA 510(k) clearance?

U1 HIP SYSTEM - BIPOLAR received FDA 510(k) clearance on 2005-08-29, under 510(k) number K050269.

Who is the listed applicant for U1 HIP SYSTEM - BIPOLAR?

The FDA 510(k) record lists United Orthopedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U1 HIP SYSTEM - BIPOLAR?

The FDA product code for U1 HIP SYSTEM - BIPOLAR is KWY.

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Other records listing United Orthopedic Corp. as applicant

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Related Devices (Code: KWY)

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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.

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