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FDA 510(k)

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS

K-Number: K120360 · 2012-05-29

ApplicantOrtho Solutions Limited
Decision Date2012-05-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions Limited. It received FDA 510(k) clearance on 2012-05-29 under 510(k) number K120360. 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 SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS?

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS is a medical device that received FDA 510(k) clearance on 2012-05-29. The listed applicant is Ortho Solutions Limited. The 510(k) number is K120360.

When did ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS receive FDA 510(k) clearance?

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS received FDA 510(k) clearance on 2012-05-29, under 510(k) number K120360.

Who is the listed applicant for ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS?

The FDA 510(k) record lists Ortho Solutions Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS?

The FDA product code for ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS is HRS.

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Other records listing Ortho Solutions Limited 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.

K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEMK111678ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISK110895ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESISK102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

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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