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FDA 510(k)

SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS

K-Number: K112900 · 2012-06-01

ApplicantLima Corporate S.P.A.
Decision Date2012-06-01
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K112900. 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 SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS?

SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K112900.

When did SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS receive FDA 510(k) clearance?

SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS received FDA 510(k) clearance on 2012-06-01, under 510(k) number K112900.

Who is the listed applicant for SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS?

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

What is the FDA product code for SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS?

The FDA product code for SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS 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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