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FDA 510(k)

SPACER-S

K-Number: K112983 · 2011-12-12

ApplicantTecres S.P.A.
Decision Date2011-12-12
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPACER-S 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 2011-12-12 under 510(k) number K112983. 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?

SPACER-S is a medical device that received FDA 510(k) clearance on 2011-12-12. The listed applicant is Tecres S.P.A.. The 510(k) number is K112983.

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

SPACER-S received FDA 510(k) clearance on 2011-12-12, under 510(k) number K112983.

Who is the listed applicant for SPACER-S?

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?

The FDA product code for SPACER-S is HSD.

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Other records listing Tecres S.P.A. as applicant

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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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