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FDA 510(k)

THE ICR KNEE

K-Number: K820719 · 1982-05-12

ApplicantAmerican Ortomed Corp.
Decision Date1982-05-12
Product Code
DecisionSubstantially Equivalent

Device Summary

THE ICR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is American Ortomed Corp.. It received FDA 510(k) clearance on 1982-05-12 under 510(k) number K820719. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ICR KNEE?

THE ICR KNEE is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is American Ortomed Corp.. The 510(k) number is K820719.

When did THE ICR KNEE receive FDA 510(k) clearance?

THE ICR KNEE received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820719.

Who is the listed applicant for THE ICR KNEE?

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

Other records listing American Ortomed Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842518UNILOC-CEMENTLESS & SELF TAP ACETABULARK842466TITANIUM MITTELMEIER TYPE ACETABULARK842465UNILOCK840413CEMENT RESTRICTORK780497SPHERISTEM TOTAL HIP PROSTHESIS

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.

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