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FDA 510(k)

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

K-Number: K011354 · 2001-07-31

ApplicantDj Orthopedics, LLC
Decision Date2001-07-31
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dj Orthopedics, LLC. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K011354. 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 HIGH TIBIAL OSTEOTOMY PLATING SYSTEM?

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Dj Orthopedics, LLC. The 510(k) number is K011354.

When did HIGH TIBIAL OSTEOTOMY PLATING SYSTEM receive FDA 510(k) clearance?

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM received FDA 510(k) clearance on 2001-07-31, under 510(k) number K011354.

Who is the listed applicant for HIGH TIBIAL OSTEOTOMY PLATING SYSTEM?

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

What is the FDA product code for HIGH TIBIAL OSTEOTOMY PLATING SYSTEM?

The FDA product code for HIGH TIBIAL OSTEOTOMY PLATING SYSTEM is HRS.

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Other records listing Dj Orthopedics, 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.

K021740TOTAL KNEE CEMENTED, SEMI-CONSTRAINEDK010594DJ ORTHOPEDICS POST SCREWK010595DJ ORTHOPEDICS INTERFERENCE SCREWK002829DJ ORTHOPEDICS FEMORAL ANCHORK003960DJ ORTHOPEDICS TIBIAL ANCHOR

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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