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FDA 510(k)

CITIEFFE TITANIUM NAILING SYSTEM

K-Number: K113387 · 2012-03-15

ApplicantCitieffe
Decision Date2012-03-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CITIEFFE TITANIUM NAILING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe. It received FDA 510(k) clearance on 2012-03-15 under 510(k) number K113387. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CITIEFFE TITANIUM NAILING SYSTEM?

CITIEFFE TITANIUM NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-15. The listed applicant is Citieffe. The 510(k) number is K113387.

When did CITIEFFE TITANIUM NAILING SYSTEM receive FDA 510(k) clearance?

CITIEFFE TITANIUM NAILING SYSTEM received FDA 510(k) clearance on 2012-03-15, under 510(k) number K113387.

Who is the listed applicant for CITIEFFE TITANIUM NAILING SYSTEM?

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

What is the FDA product code for CITIEFFE TITANIUM NAILING SYSTEM?

The FDA product code for CITIEFFE TITANIUM NAILING SYSTEM is HSB.

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Other records listing Citieffe as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113388CITIEFFE-TITANIUM CANNULATED SCREWK113384EXTERNAL FIXATOR ST.A R 90 F4

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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