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FDA 510(k)

DC ULNAR SHORTENING SYSTEM

K-Number: K073228 · 2008-02-29

ApplicantOrthopro, LLC
Decision Date2008-02-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DC ULNAR SHORTENING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopro, LLC. It received FDA 510(k) clearance on 2008-02-29 under 510(k) number K073228. 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 DC ULNAR SHORTENING SYSTEM?

DC ULNAR SHORTENING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-29. The listed applicant is Orthopro, LLC. The 510(k) number is K073228.

When did DC ULNAR SHORTENING SYSTEM receive FDA 510(k) clearance?

DC ULNAR SHORTENING SYSTEM received FDA 510(k) clearance on 2008-02-29, under 510(k) number K073228.

Who is the listed applicant for DC ULNAR SHORTENING SYSTEM?

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

What is the FDA product code for DC ULNAR SHORTENING SYSTEM?

The FDA product code for DC ULNAR SHORTENING SYSTEM is HRS.

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Other records listing Orthopro, 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.

K122936ANKLE TRAUMA SYSTEMK113006I-FUSE HAMMER TOE SYSTEMSK093055CSTS SCREWK070555ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRESK071243METAL HEMI IMPLANTK062908ORTHROPRO HEMI TOE

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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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