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FDA 510(k)

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX

K-Number: K113733 · 2012-03-23

ApplicantNeoortho Produtos Ortopedicos S/A
Decision Date2012-03-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopedicos S/A. It received FDA 510(k) clearance on 2012-03-23 under 510(k) number K113733. 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 SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX?

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX is a medical device that received FDA 510(k) clearance on 2012-03-23. The listed applicant is Neoortho Produtos Ortopedicos S/A. The 510(k) number is K113733.

When did SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX receive FDA 510(k) clearance?

SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX received FDA 510(k) clearance on 2012-03-23, under 510(k) number K113733.

Who is the listed applicant for SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX?

The FDA 510(k) record lists Neoortho Produtos Ortopedicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX?

The FDA product code for SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX is HRS.

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Other records listing Neoortho Produtos Ortopedicos S/A 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.

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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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