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FDA 510(k)

EXTERNAL FIXATOR ST.A R 90 F4

K-Number: K113384 · 2012-05-01

ApplicantCitieffe
Decision Date2012-05-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTERNAL FIXATOR ST.A R 90 F4 is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K113384. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL FIXATOR ST.A R 90 F4?

EXTERNAL FIXATOR ST.A R 90 F4 is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Citieffe. The 510(k) number is K113384.

When did EXTERNAL FIXATOR ST.A R 90 F4 receive FDA 510(k) clearance?

EXTERNAL FIXATOR ST.A R 90 F4 received FDA 510(k) clearance on 2012-05-01, under 510(k) number K113384.

Who is the listed applicant for EXTERNAL FIXATOR ST.A R 90 F4?

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 EXTERNAL FIXATOR ST.A R 90 F4?

The FDA product code for EXTERNAL FIXATOR ST.A R 90 F4 is KTT.

Related Clinical Trials

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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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 SCREWK113387CITIEFFE TITANIUM NAILING SYSTEM

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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