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FDA 510(k)

SBI HAND FIXATION SYSTEM (TM)

K-Number: K050462 · 2005-04-26

ApplicantSmall Bone Innovations, LLC
Decision Date2005-04-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI HAND FIXATION SYSTEM (TM) 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 2005-04-26 under 510(k) number K050462. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI HAND FIXATION SYSTEM (TM)?

SBI HAND FIXATION SYSTEM (TM) is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Small Bone Innovations, LLC. The 510(k) number is K050462.

When did SBI HAND FIXATION SYSTEM (TM) receive FDA 510(k) clearance?

SBI HAND FIXATION SYSTEM (TM) received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050462.

Who is the listed applicant for SBI HAND FIXATION SYSTEM (TM)?

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 HAND FIXATION SYSTEM (TM)?

The FDA product code for SBI HAND FIXATION SYSTEM (TM) is HRS.

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 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 WRISTFITK051605SBI K-WIRES

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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