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FDA 510(k)

DIAPHYSEAL PLATE

K-Number: K060294 · 2006-03-22

ApplicantHand Innovations, LLC
Decision Date2006-03-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIAPHYSEAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, LLC. It received FDA 510(k) clearance on 2006-03-22 under 510(k) number K060294. 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 DIAPHYSEAL PLATE?

DIAPHYSEAL PLATE is a medical device that received FDA 510(k) clearance on 2006-03-22. The listed applicant is Hand Innovations, LLC. The 510(k) number is K060294.

When did DIAPHYSEAL PLATE receive FDA 510(k) clearance?

DIAPHYSEAL PLATE received FDA 510(k) clearance on 2006-03-22, under 510(k) number K060294.

Who is the listed applicant for DIAPHYSEAL PLATE?

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

What is the FDA product code for DIAPHYSEAL PLATE?

The FDA product code for DIAPHYSEAL PLATE is HRS.

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Other records listing Hand 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.

K061748FRAGMENT PLATE SYSTEMK060864MULTIDIRECTIONAL THREADED PEGK060290SHOULDER FIXATION SYSTEMK052294SHOULDER NAIL PLATEK052248DORSAL NAIL PLATE, ANATOMICALK051728MODIFICATION TO SHOULDER FIXATION SYSTEM

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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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