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FDA 510(k)

NEXA BONE PLATE AND SCREW SYSTEM

K-Number: K053408 · 2005-12-22

ApplicantNexa Orthopedics, Inc.
Decision Date2005-12-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXA BONE PLATE AND SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Orthopedics, Inc.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K053408. 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 NEXA BONE PLATE AND SCREW SYSTEM?

NEXA BONE PLATE AND SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K053408.

When did NEXA BONE PLATE AND SCREW SYSTEM receive FDA 510(k) clearance?

NEXA BONE PLATE AND SCREW SYSTEM received FDA 510(k) clearance on 2005-12-22, under 510(k) number K053408.

Who is the listed applicant for NEXA BONE PLATE AND SCREW SYSTEM?

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

What is the FDA product code for NEXA BONE PLATE AND SCREW SYSTEM?

The FDA product code for NEXA BONE PLATE AND SCREW SYSTEM is HRS.

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Other records listing Nexa Orthopedics, Inc. 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.

K072710NEXFIX COMPRESSION PINK071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMK070688NEXFIX COMPRESSION STAPLEK060386NEXA CARPO METACARPAL IMPLANTK060071NEXA COMPRESSION SCREWK053394NEXA BONE SCREW SYSTEM

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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

View on FDA Database →

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

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