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FDA 510(k)

IOI BIPOLAR PROSTHESIS

K-Number: K873815 · 1987-10-28

ApplicantIntermedics Orthopedics
Decision Date1987-10-28
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IOI BIPOLAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1987-10-28 under 510(k) number K873815. 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 IOI BIPOLAR PROSTHESIS?

IOI BIPOLAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Intermedics Orthopedics. The 510(k) number is K873815.

When did IOI BIPOLAR PROSTHESIS receive FDA 510(k) clearance?

IOI BIPOLAR PROSTHESIS received FDA 510(k) clearance on 1987-10-28, under 510(k) number K873815.

Who is the listed applicant for IOI BIPOLAR PROSTHESIS?

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

What is the FDA product code for IOI BIPOLAR PROSTHESIS?

The FDA product code for IOI BIPOLAR PROSTHESIS 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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