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FDA 510(k)

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM

K-Number: K030198 · 2003-04-01

ApplicantHand Innovations, Inc.
Decision Date2003-04-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, Inc.. It received FDA 510(k) clearance on 2003-04-01 under 510(k) number K030198. 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 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM?

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-01. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K030198.

When did HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM receive FDA 510(k) clearance?

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM received FDA 510(k) clearance on 2003-04-01, under 510(k) number K030198.

Who is the listed applicant for HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM?

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

What is the FDA product code for HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM?

The FDA product code for HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM is HRS.

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Other records listing Hand Innovations, Inc. 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.

K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMK042059SHOULDER FIXATION SYSTEMK041157MODIFICATION TO SMALL BONE FIXATION SYSTEMK041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESK033406SMALL BONE FIXATION SYSTEMK032705DISTAL RADIUS FRACTURE REPAIR 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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