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FDA 510(k)

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES

K-Number: K012377 · 2002-03-11

ApplicantCorin USA
Decision Date2002-03-11
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2002-03-11 under 510(k) number K012377. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES?

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES is a medical device that received FDA 510(k) clearance on 2002-03-11. The listed applicant is Corin USA. The 510(k) number is K012377.

When did OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES receive FDA 510(k) clearance?

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES received FDA 510(k) clearance on 2002-03-11, under 510(k) number K012377.

Who is the listed applicant for OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES?

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 OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES?

The FDA product code for OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES is HSD.

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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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