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FDA 510(k)

THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM

K-Number: K972995 · 1997-11-10

ApplicantCorin USA
Decision Date1997-11-10
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K972995. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM?

THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Corin USA. The 510(k) number is K972995.

When did THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 1997-11-10, under 510(k) number K972995.

Who is the listed applicant for THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM?

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

What is the FDA product code for THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM?

The FDA product code for THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM is JDI.

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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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