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FDA 510(k)

ORTHOPEDIATRICS PLATING SYSTEM

K-Number: K073344 · 2008-02-19

ApplicantOrthopediatrics, LLC
Decision Date2008-02-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIATRICS PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopediatrics, LLC. It received FDA 510(k) clearance on 2008-02-19 under 510(k) number K073344. 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 ORTHOPEDIATRICS PLATING SYSTEM?

ORTHOPEDIATRICS PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-19. The listed applicant is Orthopediatrics, LLC. The 510(k) number is K073344.

When did ORTHOPEDIATRICS PLATING SYSTEM receive FDA 510(k) clearance?

ORTHOPEDIATRICS PLATING SYSTEM received FDA 510(k) clearance on 2008-02-19, under 510(k) number K073344.

Who is the listed applicant for ORTHOPEDIATRICS PLATING SYSTEM?

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

What is the FDA product code for ORTHOPEDIATRICS PLATING SYSTEM?

The FDA product code for ORTHOPEDIATRICS PLATING SYSTEM is HRS.

Related Clinical Trials

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Other records listing Orthopediatrics, 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.

K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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