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FDA 510(k)

IOI METAL BACKED TIBIAL COMPONENT

K-Number: K821341 · 1982-06-03

ApplicantIntermedics Orthopedics
Decision Date1982-06-03
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IOI METAL BACKED TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821341. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOI METAL BACKED TIBIAL COMPONENT?

IOI METAL BACKED TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Intermedics Orthopedics. The 510(k) number is K821341.

When did IOI METAL BACKED TIBIAL COMPONENT receive FDA 510(k) clearance?

IOI METAL BACKED TIBIAL COMPONENT received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821341.

Who is the listed applicant for IOI METAL BACKED TIBIAL COMPONENT?

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 METAL BACKED TIBIAL COMPONENT?

The FDA product code for IOI METAL BACKED TIBIAL COMPONENT is HRY.

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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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