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FDA 510(k)

MINI RAIL EXTERNAL FIXATOR SYSTEM

K-Number: K093550 · 2010-01-07

ApplicantSmall Bone Innovations, Inc.
Decision Date2010-01-07
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI RAIL EXTERNAL FIXATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Small Bone Innovations, Inc.. It received FDA 510(k) clearance on 2010-01-07 under 510(k) number K093550. 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 MINI RAIL EXTERNAL FIXATOR SYSTEM?

MINI RAIL EXTERNAL FIXATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K093550.

When did MINI RAIL EXTERNAL FIXATOR SYSTEM receive FDA 510(k) clearance?

MINI RAIL EXTERNAL FIXATOR SYSTEM received FDA 510(k) clearance on 2010-01-07, under 510(k) number K093550.

Who is the listed applicant for MINI RAIL EXTERNAL FIXATOR SYSTEM?

The FDA 510(k) record lists Small Bone Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI RAIL EXTERNAL FIXATOR SYSTEM?

The FDA product code for MINI RAIL EXTERNAL FIXATOR SYSTEM is KTT.

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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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