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FDA 510(k)

ORTHO SELECT BONE PLATES AND SCREW SYSTEM

K-Number: K091493 · 2010-02-05

ApplicantOrtho Select Implant Technology Gesellschaft
Decision Date2010-02-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO SELECT BONE PLATES AND SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Select Implant Technology Gesellschaft. It received FDA 510(k) clearance on 2010-02-05 under 510(k) number K091493. 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 ORTHO SELECT BONE PLATES AND SCREW SYSTEM?

ORTHO SELECT BONE PLATES AND SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-05. The listed applicant is Ortho Select Implant Technology Gesellschaft. The 510(k) number is K091493.

When did ORTHO SELECT BONE PLATES AND SCREW SYSTEM receive FDA 510(k) clearance?

ORTHO SELECT BONE PLATES AND SCREW SYSTEM received FDA 510(k) clearance on 2010-02-05, under 510(k) number K091493.

Who is the listed applicant for ORTHO SELECT BONE PLATES AND SCREW SYSTEM?

The FDA 510(k) record lists Ortho Select Implant Technology Gesellschaft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO SELECT BONE PLATES AND SCREW SYSTEM?

The FDA product code for ORTHO SELECT BONE PLATES AND SCREW SYSTEM is HRS.

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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

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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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