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FDA 510(k)

PIVOT BIPOLAR FEMORAL HEAD

K-Number: K050966 · 2005-07-07

ApplicantOrtho Development Corp.
Decision Date2005-07-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIVOT BIPOLAR FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2005-07-07 under 510(k) number K050966. 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 PIVOT BIPOLAR FEMORAL HEAD?

PIVOT BIPOLAR FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Ortho Development Corp.. The 510(k) number is K050966.

When did PIVOT BIPOLAR FEMORAL HEAD receive FDA 510(k) clearance?

PIVOT BIPOLAR FEMORAL HEAD received FDA 510(k) clearance on 2005-07-07, under 510(k) number K050966.

Who is the listed applicant for PIVOT BIPOLAR FEMORAL HEAD?

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

What is the FDA product code for PIVOT BIPOLAR FEMORAL HEAD?

The FDA product code for PIVOT BIPOLAR FEMORAL HEAD is 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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