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FDA 510(k)

SBI K-WIRES

K-Number: K051605 · 2005-08-10

ApplicantSmall Bone Innovations, LLC
Decision Date2005-08-10
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI K-WIRES is the device name listed in this FDA 510(k) record. The listed applicant is Small Bone Innovations, LLC. It received FDA 510(k) clearance on 2005-08-10 under 510(k) number K051605. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI K-WIRES?

SBI K-WIRES is a medical device that received FDA 510(k) clearance on 2005-08-10. The listed applicant is Small Bone Innovations, LLC. The 510(k) number is K051605.

When did SBI K-WIRES receive FDA 510(k) clearance?

SBI K-WIRES received FDA 510(k) clearance on 2005-08-10, under 510(k) number K051605.

Who is the listed applicant for SBI K-WIRES?

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

What is the FDA product code for SBI K-WIRES?

The FDA product code for SBI K-WIRES is HTY.

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Other records listing Small Bone Innovations, LLC 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.

K052576SBI AUTOFIXK051747SBI WRISTFITK050462SBI HAND FIXATION SYSTEM (TM)

Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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