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FDA 510(k)

SPACER-S TEMPORARY SHOULDER SPACER

K-Number: K060535 · 2006-05-24

ApplicantTecres S.P.A.
Decision Date2006-05-24
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPACER-S TEMPORARY SHOULDER SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2006-05-24 under 510(k) number K060535. 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 SPACER-S TEMPORARY SHOULDER SPACER?

SPACER-S TEMPORARY SHOULDER SPACER is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Tecres S.P.A.. The 510(k) number is K060535.

When did SPACER-S TEMPORARY SHOULDER SPACER receive FDA 510(k) clearance?

SPACER-S TEMPORARY SHOULDER SPACER received FDA 510(k) clearance on 2006-05-24, under 510(k) number K060535.

Who is the listed applicant for SPACER-S TEMPORARY SHOULDER SPACER?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPACER-S TEMPORARY SHOULDER SPACER?

The FDA product code for SPACER-S TEMPORARY SHOULDER SPACER is HSD.

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Related Devices (Code: 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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